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DRAFT law No. 151/X (REGULATING MEDICALLY ASSISTED PROCREATION TECHNIQUES) explanatory memorandum the infertility of couples wishing to have children is growing and widespread disease incidence, whose solution intended progressively effective in a society more free from prejudices, enriched with constant scientific advances and endowed with unusual Resolutive capacity differentiated technologies. The adoption, while alternative method for such couples, not always can provide the desired results, for reasons known, of diverse nature. Moreover, our cultural and social values it inculcates, with particular emphasis, the idea of marriage procreation as a means to ensure the sustainability, not only from a wide range of axiológicas references but also a genetic heritage jealously preserved. The pointed to constraints have legitimized the search for alternative solutions to achieve a desideratum that the biological mechanisms of human reproduction may not, in certain circumstances, provide. It is therefore necessary to intervene in legislative terms, in the construction of a system that, together with the necessary investigation of causes or factors of infertility with a view to your prevention, and according to the guidelines of the World Health Organization, establish concrete steps for action in the strategic aspects of family medicine, fertility and human reproduction. The coherent integration of such a network in the operating model of the maternal and child health care ends up become essential the promulgation of logically a legal regime that set and watch the action rules on specific aspects of medically assisted procreation, as only the top level of an escalation in the area of human reproduction interventionist. The absence, in Portugal, of specific legislation in this area has been the subject of diverse positions. If you have already stated that they will not be necessary laws PARLIAMENT 2 to treat patients and, on the other hand, has relied on the urgent need for rules and limits, since no law everything is permitted because nothing is outside the law. A middle position could recommend a regulatory framework only limited consensual aspects of a problem continues, more and more, to be the subject of heated controversy. The legislative inertia, regardless of legal Quadrant in which place, represents in itself a choice of values. Without law, boundaries, except to ethics, morals and the individual conscience is the only technically feasible. Well, it's not excluded that socially significant sectors may be on or absolutely, unaware of the imperatives of conscience, because seduced by a mirífica omnipotence of technical progress and of its possible benefits. In every society there are groups that do not conceive the technique without ethics, other there for whom the eminently technical instrumental character turns out to be absolutizado and erected the category only to ethics: should be an end in itself. The absence of legislation on medically assisted procreation motivates still understandable difficulties in determining rights and responsibilities of the various parties involved in the acts of each procedure. Decree-Law No. 319/86, of 25 September, intended to establish the conditions for the authorisation of acts required by the techniques of medically assisted procreation, which should, however, be laid down in implementing decree. However, this regulation was never produced. The National Council of ethics for the life sciences announced in February 1993, an extensive report and opinion medically assisted reproduction (3/CNE/93), which came to define the ethical principles that should be implicit in the practices of medically assisted procreation. Also the law No. 12/93, of 22 April, concerning the collection and transplantation of organs and tissues of human origin, establishes in paragraph 2 of article 1, that ' the gift of eggs and sperm and the transfer and manipulation of embryos are the subject of special legislation '.
ASSEMBLY of the REPUBLIC 3 later, in 1995, the report and opinion No. 15/95, Council/CNEV national ethics for the life sciences, came to the urgent need to produce legislation on human embryo, in particular in order to prevent the production of embryos for research purposes. This Council has also published the opinion No. 18/CNECV/97, on legal protection of biotechnological inventions; No. 21/CNECV/97, on cloning; No. 22/CNECV/97, on in vitro diagnostic medical devices; No. 25/CNECV/98, about therapeutic use of biological products; and no. 31/CNECV/2000 on the human genome. It was considered that it called, therefore, implement measures to acautelassem the principles that underlie issues that have to do with the defense of freedom and human dignity, with social solidarity and health intervention and its requirement of quality of the services provided. Is that, ultimately, the rapid technological development and the overwhelming scientific progress will have to be put at the service of mankind and exclusively to your right. In this sense it was understood by the then Government, in 1997, to introduce a bill that colmatasse this important gap in the Portuguese legal system. He considered that the possible regulations should result from a membership of opinions that caucionassem the choices, which, however, would not let them certainly be contested by some. It was considered, then, and it is considered today that the essential requirement will have to be managed in accordance with principles, standards and recommendations from national and supra-national institutions and accredited in uncompromising defense of fundamental principles, among which would be highlighted the respect for the dignity of the human person, the inviolability and inalienability your. In this context, could not yet be ignored if the essential safety you have to earn the human genetic material and the required guarantee technical quality and humanization of the services provided.
ASSEMBLY OF THE REPUBLIC
4 this position remains all the more so since the Decree 415/VII (resulting from the proposal of law No. 135/VII) turned out to be subject to veto by the President of the Republic. It should be noted that, following the IV Constitutional review process of 1997, article 26, paragraph 2, came to establish the legal guarantee of the personal dignity and the genetic identity of human beings, in particular in the creation, development and use of technologies and scientific experimentation, in tune with the new contributions of the Council of Europe, in particular by means of the Bioethics Convention, at the time of consecration in the Portuguese legal order pendant. It was ratified by the Portuguese Parliament however the Convention on human rights and Biomedicine of the Council of Europe that became part of our legal system and laying down some general principles which fall under the action in these areas. Even this fact is evidenced the importance of rigor which define legally permissible techniques, the conditions under which permitted the use of such techniques and which enabled institutions to this end. In short, it must be established a normative framework that effectively, prudence and reasonableness to fulfill a mission where the facilities do not pontifiquem. Therefore, you cannot assume positions fundamentalists, but before there is for and all that, according to the data of science, dignifies the human person, repudiating what can demean and looking out of a such an attitude of mind the consequences that they consider fair, humane and even in line with the feel and the values of the national community. Accordingly it is assumed, in legislative initiative now present, the defence of the principles set out below: a) the different medically assisted procreation techniques involving gamética or handling are not embryonic alternative mode of procreation, but before the alternative method to be used only when there are proven changes PARLIAMENT 5 of the physiological mechanisms of reproduction or when faced with medical indications for the prevention or treatment of genetic diseases , infectious or other; b) the use of medically assisted procreation shall ensure conditions for your child integral development, particularly the right to benefit from the family structure, biparental, of membership. So, should only be eligible for medically assisted procreation techniques heterosexual couples, relationship stability, unless in very exceptional situations; c) the acts required by the medically assisted procreation techniques have to be practised in establishments with technical and scientifically-proven integrity and will have to be subject to periodic review and inspection; d) must be guaranteed the confidentiality of documents in relation to the participants of the techniques of medically assisted procreation, just being able to be broken the secrecy for medical reasons justified or other equally powerful; and biological product) Nature Genetics which is subject to donation cannot under any circumstances be traded or may be assigned any commercial value; f) is mandatory in all acts concerning medically assisted procreation techniques the express consent, free and clear, by the respective beneficiaries and stakeholders, being guaranteed to health professionals the right to conscientious objection must be made explicit; g) should be considered prohibited purposes of medically assisted procreation techniques those seeking certain genetic characteristics of the unborn child, involving the creation of human clones, chimeras, or interspecies fertilization and even motherhood and the post-mortem conception, except in circumstances specifically provided for conditioned the assessment and decision of National Council for medically assisted Reproduction (CNRMA).
ASSEMBLY of the REPUBLIC 6:00) advocates the legalization of semen conservation units, once the gift of male gametes must not deny that assumed all the consequences that may result from such an act by the potential beneficiaries. This is the only way to guarantee the technical quality of the units involved in the process, avoiding at the same time, an undesirable underground, the possible social and economic discrimination and even an intolerable human biological products. Preserves the possibility of material interests are the subject of dispute, as far as not fit for donors any powers or duties in respect of children who will be born as a result of artificial insemination with semen donated; I) the donation of oocytes, taking into consideration the technical impossibility of freeze the female gamete identically to that of the male gametes, should only be able to check-in conditions which ensure the anonymity of those involved; j) the deliberate creation of supernumerary embryos should not take place under current practice of medically assisted procreation, which recommends that the number of oocytes to inseminate in each cycle of in vitro fertilization should depend on the number of embryos to be transferred and the clinical situation-specific laboratory; l) May occur creating embryos that later will not be transferred to the uterus, if your freezer is advocated for later transfer to the recipient couple. Exceptionally, when this transfer cannot be put into practice and by the consent of the beneficiaries can embryos be destined for another couple, whose diagnosis of infertility advise, or donated for scientific research. m) provides for the Constitution of the National Council of medically assisted Reproduction for orientation, decision and follow-up in the context of medically assisted procreation.
ASSEMBLY of the REPUBLIC 7 accordingly, and pursuant to article 167 and in accordance with point (b)) of paragraph 1 of article 165 of the Constitution of the Portuguese Republic, the deputies of the Socialist Party feature the following Bill: chapter I General provisions Article 1 subject-matter this law is to regulate the following techniques of medically assisted procreation:
the) artificial insemination; b) in vitro fertilization; c) intra-cytoplasmic sperm injection; d) the transfer of gametes, zygotes or embryos for the Horn; and generic pre-deployment diagnosis); f) Other laboratory techniques of manipulating embryonic equivalent or subsidiaries or gamética.
Article 2 eligibility Condition 1 — the use of techniques of medically assisted reproduction can only occur after rigorous diagnosis of infertility, certified by medical team to which at least two qualified specialists with a minimum of five years of activity in medical areas related to human reproduction or adoption in course of study in medicine of reproduction.
ASSEMBLY of the REPUBLIC 8 2 — is, however, permissible use of medically assisted procreation techniques in order to carry out the prevention or the treatment of genetic anomalies, infectious or another.
Article 3 approved centres and qualified people 1 — The medically assisted procreation techniques may only be administered under the direct supervision and responsibility of qualified medical specialist, in public or private centres expressly authorized for the purpose by the Minister of health. 2 — the centres referred to in the preceding paragraph shall be subject to periodic assessment of quality. Article 4 Beneficiaries 1 — Just married people who are not legally separate terms or separate in fact, or that being of different sex living in conditions similar to those of spouses, for at least two years, can resort to medically assisted procreation techniques. 2 — the techniques may be used only for the benefit of those who have at least 18 years of age and not prohibited or disqualified for psychic anomaly. 3 — Without prejudice to article 28, can only be beneficiary of medically assisted procreation techniques that contribute to gametes of at least one of its members.
Article 5 ASSEMBLY of the REPUBLIC 9 1 — prohibited Purposes is prohibited the use of medically assisted procreation techniques with the deliberate aim to create identical human beings by cloning, among other things, or to give rise to chimeras or to take interspecies fertilization. 2 — Without prejudice to the provisions of paragraph 2 of article 2, the medically assisted procreation techniques cannot be used to achieve certain characteristics of the unborn child, such as the choice of sex.
Article 6 1 replacement mother — the term replacement maternity any situation in which the woman is willing to support a pregnancy on behalf of third parties and return the child after birth, resigning to the powers and duties of motherhood. 2 — is restricted the use of maternity leave replacement, to the CNRMA. 3 — are null the legal transactions, costly, maternity. 4 — with the exception of the cases provided for in paragraph 2, the woman who bear a pregnancy in place of another person is considered for all legal purposes as the mother of the child which will be born.
Article 7 use of embryos for research purposes 1-the use of viable embryos for scientific research purposes is only allowed with diagnostic or therapeutic targets and will be subject to the assessment and decision of CNRMA.
ASSEMBLY of the REPUBLIC 10 2 — will only be allowed preimplantation genetic diagnosis techniques of recognized scientific value to the diagnosis or treatment of genetic diseases or other. 3 — the deliberate creation of embryos for research purposes or scientific experimentation.
Chapter II use of medically assisted procreation techniques article 8 medical decision and conscientious objection 1 — the doctor responsible proposes to beneficiaries to medically assisted reproduction technique that, scientifically, appears most appropriate when other treatments have not been successful, does not offer prospects of success or not prove convenient according to the precepts of medical knowledge. 2 — no health professional may be required to oversee or to cooperate in carrying out any of the techniques of medically assisted procreation, for medical reasons or ethical, not the duty to do. 3 — the refusal of professional must specify the clinical reasons or of another nature, therefor namely conscientious objection.
Article 9 beneficiaries ' Rights Are rights of beneficiaries: ASSEMBLY of the REPUBLIC the 11) not to be subjected to techniques which do not offer reasonable chances of success or the use of which behave significant risks to the health of the mother or the child; b) Be assisted in appropriate medical environment, with all the material and human conditions required for the proper execution of technique advisable; c) be properly informed about the medical, social and legal implications likely proposed treatments; d) know the reasons that motivate the refusal of medically assisted procreation techniques; and) Be informed of the conditions under which they would be possible to resort to adoption and the social relevance of this Institute.
Article 10 obligations of beneficiaries 1 — Are duties of beneficiaries: a) Provide all information they are requested by medical staff or to understand relevant for the proper diagnosis of your clinical situation and to the success of the technique that will undergo; b) observe all the requirements of the medical team, both during the diagnostic phase, during the different stages of the process of medically assisted procreation;
2 — in order to be globally evaluated the results and psycho-sociological médico-sanitários of medically assisted reproduction processes, should the beneficiaries provide all information related to the health, development and family integration of the children born to him taught techniques.
ASSEMBLEIA DA REPÚBLICA 12 article 11 Consent
1 — The beneficiaries must provide your informed consent, savvy, expressly and in writing, before the doctor in charge. 2 — for the purposes of the preceding paragraph, shall be previously informed beneficiaries in writing of all benefits and known risks resulting from the use of the techniques of medically assisted procreation, as well as its ethical, social and legal implications. 3 — the data referred to in the preceding paragraph shall contain the document through which beneficiaries pay the your consent. 4 — the beneficiaries ' consent is freely revocable by any of them until the beginning of the therapeutic processes referred to in article 1.
Article 12 Confidentiality 1 — all those who, by some way, taking knowledge of the techniques of medically assisted procreation, or the identity of any of the participants in their processes, are obliged not to reveal the identity of the same and the secrecy of their own act of assisted procreation. 2 — people born as a result of medically assisted reproduction processes using the donation of gametes or embryos may with the competent health services, obtain the information concerning them, excluding the identification of the donor. 3 — in addition to the preceding paragraph, the people there referred to may obtain information concerning the identification of the donor, for serious reasons recognized by judicial sentence, and the Court with jurisdiction in family matters in the area of PARLIAMENT 13 residence of the person concerned will be able to CNRMA info on existence of an impediment pursuant to article 1,602 of the Civil Code. 4 — for the purposes of the preceding paragraphs is not required the consent of the donor.
Article 13 registration and data retention 1 — will be set, by order of the competent Ministers in the areas of health and Justice, the way should be organized data records relating to medically assisted reproduction processes, their beneficiaries, donors and children born, as well as the conditions and the licensing of establishments in which she will perform. 2 — the same degree shall establish the period of time during which they must be stored data , who may have access to them, and for what purpose, as well as the cases that can be disposed of information contained in the records.
Article 14 1 — Charges The establishments authorized to provide medically assisted procreation techniques may not, in calculating the compensation payable, assign any value to the donated genetic material or embryos referred to in paragraph 4 of article 21. 2 — the use of techniques of medically assisted procreation in the context of the national health service will be supported under the conditions that may be set in own diploma.
ASSEMBLEIA DA REPÚBLICA 14 Chapter III article 15 artificial Insemination with donor semen Insemination 1 — the insemination with semen of a third donor can only occur when, in the face of knowledge médico-científicos objectively available, can't get pregnant through artificial insemination with semen from her husband or that living in consensual union with the woman to inseminate. 2 — the semen of the donor must be cryopreserved. 3 — situations in which it is permissible to the donation of semen and resource requirements for donors and beneficiaries, as well as the rules of functioning of Semen conservation units, shall be laid down by Ordinance provided for in article 13.
Article 16 Determination of paternity — 1 If insemination referred to in the previous article were to result in the birth of a child will be there as a child of this husband or that living in de facto union with his wife inseminated, since this there is consented to insemination, in accordance with article 11. 2 — for the purposes of the preceding paragraph shall be displayed, in the Act of birth registration, proof that the man living in consensual union with the mother of the child provided the consent provided for in article 11. 3 — not having been consent, plough-birth registration shall be only with motherhood, in which case does not apply the provisions of articles 1864.º to 1866.º of the Civil Code.
ASSEMBLEIA DA REPÚBLICA 15 4 — the presumption of paternity established pursuant to paragraph 1 may be challenged by her husband or one who lives in domestic partnership is proved that there was no consent, or that the son was not born of insemination to that consent was provided.
Article 17 Exclusion of paternity 1 semen donor — the donor semen cannot be there as father of the child which will be born not fitting any powers or duties towards her. 2 — the provisions of the preceding paragraph shall not preclude the admissibility, in preliminary process of publications, of proof of paternity for the purposes of (a)) and (b)) of article 1602.º of the Civil Code.
Article 18 ban on post-mortem insemination 1 — after the death of the husband or the man who lived in a de facto Union is not permissible for woman to be inseminated with sperm from the deceased, although this there is consented to the Act of insemination. 2 — the sperm with founded fear of future sterility, is collected for purposes of insemination of the spouse or of the woman the man lives in domestic partnership will be destroyed if that comes to pass away during the period established for the conservation of semen. 3 — is, however, lawful post mortem of embryo implantation, to allow the establishment of a parental project clearly established in writing before the death of the father, that is the period considered appropriate the weighting adjusted to the decision.
ASSEMBLY of the REPUBLIC 16 Article 19 1 — if Paternity of the breach of the prohibition referred to in the preceding article result inseminated woman's pregnancy, the child to be born is considered as a daughter of the late. 2 — the preceding paragraph if the date of insemination, the woman has contracted marriage or live, for at least two years, in de facto union with man who, pursuant to article 11, get your consent to such an Act, in which case applies the provisions of paragraph 3 of article 1839.º of the Civil Code.
Chapter IV in vitro Fertilization article 20 general principle
1 — In IVF should only be to the creation of embryos in number considered necessary for the success of the process, according to good clinical practice and the principle of informed consent. 2-the number of oocytes to inseminate in each process must take into account the clinical situation and the general indication of prevention of multiple pregnancy.
Article 21 1 embryos ' fate — embryos that, pursuant to the preceding paragraph, have not been transferred must be frozen, pledging the recipients to use them in new embryo transfer process within three years.
PARLIAMENT 17 2 – within three years can embryos be destined for another couple whose medical indications of infertility advise, being the facts justifying registered determinants. 3 — the fate of embryos referred to in the preceding paragraph may only occur upon the consent of the intended beneficiaries, or what it is going to survive, by applying, mutatis mutandis, the provisions of paragraph 1 of article 11. 4-shall not be subject to the provisions of paragraph 1 the embryos whose morphological characterization does not indicate minimum conditions of viability. 5-the other embryos shall apply the provisions of paragraph 1 of article 7.
Article 22 in vitro Fertilization post mortem If the one who deposited the semen for the purposes of your fertilization for the benefit of the couple to which he belongs, vier died applies, with any necessary adaptations, the available relating to post-mortem insemination in articles 18, paragraphs 1 and 2, and 19.
Article 23 in vitro Fertilization with semen from the donor in vitro fertilization using donor semen shall apply, mutatis mutandis, the provisions of articles 15 to 17 Article 24 Donation of oocytes Can be applied to the donation of oocytes when, in the face of medical and scientific knowledge objectively available, can't get pregnant through PARLIAMENT 18 any other technique and provided they are ensured effective conditions to ensure the anonymity of those involved , donor and beneficiaries.
Article 25 1 Motherhood — the donor oocytes can not be considered as the mother of the child which will be born not fitting any powers or duties towards her. 2 — the provisions of the preceding paragraph shall not preclude the admissibility, in preliminary process of publications, the proof of maternity for the purposes of (a)) and (b)) of article 1602.º of the Civil Code.
Article 26 Beneficiaries of embryos 1 — Being the embryos intended for another couple in accordance with paragraph 3 of article 21, must be privileged couples who have no children, natural or adopted. 2 — the beneficiaries of embryos must not be older than 45 years and 55 years woman the man. 3 — for the purposes of determination of motherhood and fatherhood shall apply, mutatis mutandis, the provisions of articles 16, 17 and 25.
Article 27 Maternity 1-replacement may be authorised by the National Council of medically assisted Reproduction, exceptionally, recourse to motherhood, according to the criteria set by the Council and when the following conditions occur: ASSEMBLY of the REPUBLIC the 19) this is the only resource to respond to the concrete situation of infertility; b) be respected the interests and rights of the spouses, the child and the mother, through informed consent from the pregnant women and future parents; c) not be practiced any remuneration, without prejudice to the compensation of expenditure incurred, objectively proven.
2 – applicable to maternity replacement, mutatis mutandis, the provisions of articles 15 to 17.
Article 28 National Council of medically assisted Reproduction 1 — is created the National Council of medically assisted Reproduction, hereinafter referred to as CNRMA, upon whom generally comment on the ethical, social and legal issues of medically assisted procreation and namely: a) give advice on public and private establishments authorised to commit medically assisted procreation techniques and monitor their activities; (b)) the information Request referred to in paragraph 2 of article 10, carry out the scientific development and evaluate your overall results médico-sanitários and psicossociológicos practice of medically assisted procreation throughout the national territory; c) Collect information on the use of the techniques of procreation indicated in article 1, to provide for mandatory physician in charge. (d)) be provided to judicial bodies the information is requested.
ASSEMBLY of the REPUBLIC 20 2 — the Organization, composition and operation of are set by the Government through CNRMA of joint Ordinance referred to in article 13.
Chapter V Penalties article 29 misuse of medically assisted procreation techniques 1 — the use of techniques of medically assisted procreation for the purposes provided for in article 5, or without the consent of any of the beneficiaries, provided in accordance with article 11, constitute a crime punishable by a prison term of one to five years. 2 — the use of techniques of assisted procreation outside of authorized institutions, without knowledge of the physician in charge or with violating the legis artis, constitute a crime punishable by imprisonment up to three years.
Article 30 replacement Maternity promotion, in any way, including through direct invitation or through an intermediary or public announcement, replacement maternity consideration constitute a crime punishable by imprisonment up to three years.
Article 31 misuse of embryos PARLIAMENT 21 1 — the deliberate creation of embryos for research purposes and the implantation of embryos that have undergone experimentation constitutes a crime punishable by a prison term of one to five years. 2 — the transfer of embryos for purposes or under conditions not allowed by law constitute a crime punishable by imprisonment up to two years.
Article 32 breach of the duty of confidentiality breach of anonymity or the duty of confidentiality, laid down in article 12, constitute a crime punishable by imprisonment up to two years.
Article 33 penalties who is convicted for the crimes provided for in the preceding articles can the Court impose the following penalties:
the temporary Ban) practice of the profession for a period of six months to two years, or definitive; b) permanent closure of private establishment where there's been committed the unlawful acts of assisted procreation; c) Advertising of enforceable judgment.
Chapter VI final provisions article 34 PARLIAMENT 22 Other medically assisted procreation techniques 1 — When used the techniques laid down in (c)) to (g)) of article 1 shall apply to: a) in the case of the use of donor semen, the provisions of chapter III shall apply mutatis mutandis; b) in the case of the use of donor oocytes, the provisions of articles 25 and 26; c the intra-cytoplasmic sperm injection), transfer of gametes or embryos for the Horn, embryo transfer to the uterus, prenatal diagnosis, preimplantation genetic diagnosis or any other laboratory techniques gamética handling or equivalent or embryonic subsidiaries, the provisions of chapter IV, with the necessary adaptations.
2 — the intervention with diagnostic or therapeutic purposes on the pre-embryo or fetus can only be used to ensure your viability, or to detect hereditary diseases or to treat a serious illness or prevent your transmission.
Article 35 three-yearly report to the Government, on the basis of the work carried out by CNRMA referred to in article 27 shall send a report to Parliament on the implementation of this law and the necessity of your amendment.
Article 36 PARLIAMENT 23 Regulations the Government will promote the publication, within 180 days of qualifications essential to the development of this law.
Members of PS A.R. 27.07.05
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