CASE OF VO v. FRANCE
Preliminary objections rejected (ratione materiae, non-exhaustion of domestic remedies);No violation of Art. 2
Luzius Wildhaber;Nicolas Bratza;Paul Mahoney
9. The applicant was born in 1967 and lives in Bourg-en-Bresse. 10. On 27 November 1991 the applicant, Mrs Thi-Nho Vo, who is of Vietnamese origin, attended Lyons General Hospital for a medical examination scheduled during the sixth month of pregnancy. 11. On the same day another woman, Mrs Thi Thanh Van Vo, was due to have a contraceptive coil removed at the same hospital. When Dr G., who was to remove the coil, called out the name “Mrs Vo” in the waiting-room, it was the applicant who answered. After a brief interview, the doctor noted that the applicant had difficulty in understanding French. Having consulted the medical file, he sought to remove the coil without examining her beforehand. In so doing, he pierced the amniotic sac causing the loss of a substantial amount of amniotic fluid. After finding on clinical examination that the uterus was enlarged, the doctor ordered a scan. He then discovered that one had just been performed and realised that there had been a case of mistaken identity. The applicant was immediately admitted to hospital. Dr G. then attempted to remove the coil from Mrs Thi Thanh Van Vo, but was unsuccessful and so prescribed an operation under general anaesthetic for the following morning. A further error was then made when the applicant was taken to the operating theatre instead of Mrs Thi Thanh Van Vo, and only escaped the surgery intended for her namesake after she protested and was recognised by an anaesthetist. 12. The applicant left the hospital on 29 November 1991. She returned on 4 December 1991 for further tests. The doctors found that the amniotic fluid had not been replaced and that the pregnancy could not continue further. The pregnancy was terminated on health grounds on 5 December 1991. 13. On 11 December 1991 the applicant and her partner lodged a criminal complaint, together with an application to join the proceedings as civil parties, alleging unintentional injury to the applicant entailing total unfitness for work for a period not exceeding three months and unintentional homicide of her child. Three expert reports were subsequently filed. 14. The first, which was filed on 16 January 1992, concluded that the foetus, a baby girl, was between 20 and 21 weeks old, weighed 375 grams, was 28 centimetres long, had a cranial perimeter of 17 centimetres and had not breathed after delivery. The expert also concluded that there was no indication that the foetus had been subjected to violence or was malformed and no evidence that the death was attributable to a morphological cause or to damage to an organ. Further, the autopsy performed after the abortion and an anatomico-pathological examination of the body indicated that the foetal lung was 20 to 24 weeks old. 15. On 3 August 1992 a second report was filed concerning the applicant’s injuries: “(a) There is a period of temporary total unfitness for work from 27 November 1991 to 13 December 1991, when the patient was admitted to the Tonkin Clinic with an entirely unconnected pathology (appendectomy) (b) the date of stabilisation can be put at 13 December 1991 (c) there is no loss of amenity (d) there is no aesthetic damage (e) there is no occupational damage (f) there is no partial permanent unfitness for work Damage in terms of pain and suffering resulting from this incident still has to be assessed. The assessment should be carried out with a doctor of Vietnamese extraction specialising in psychiatry or psychology.” 16. The third report, which was issued on 29 September 1992, referred to the malfunctioning of the hospital department concerned and to negligence on the part of the doctor: “1. The manner in which appointments in the departments run by Professors [T.] and [R.] at Lyons General Hospital are organised is not beyond reproach, in particular in that namesakes are common among patients of foreign origin and create a risk of confusion, a risk that is undoubtedly increased by the patients’ unfamiliarity with or limited understanding of our language. 2. The fact that patients were not given precise directions and the consulting rooms and names of the doctors holding surgeries in them were not marked sufficiently clearly increased the likelihood of confusion between patients with similar surnames and explains why, after Dr [G.] had acquainted himself with Mrs Thi Thanh Van Vo’s medical file, it was [the applicant] who came forward in response to his call. 3. The doctor acted negligently, by omission, and relied solely on the paraclinical examinations. He did not examine his patient and by an unfortunate error ruptured the amniotic sac, causing the pregnancy to terminate at five months. He is accountable for that error, although there are mitigating circumstances.” 17. On 25 January 1993, and also following supplemental submissions by the prosecution on 26 April 1994, Dr G. was charged with causing unintentional injury at Lyons on 27 November 1991 by: (i) through his inadvertence, negligent act or inattention, perforating the amniotic sac in which the applicant’s live and viable foetus was developing, thereby unintentionally causing the child’s death (a criminal offence under Article 319 of the former Criminal Code – which was applicable at the material time – now Article 221-6 of the Criminal Code); (ii) through his inadvertence, negligent act, inattention, negligent omission or breach of a statutory or regulatory duty of protection or care, causing the applicant bodily injury that resulted in her total unfitness for work for a period not exceeding three months (a criminal offence under Article R. 40, sub-paragraph 4, of the former Criminal Code – which was applicable at the material time – now Articles R. 625-2 and R. 625-4 of the Criminal Code). 18. By an order of 31 August 1995, Dr G. was committed to stand trial in the Lyons Criminal Court on counts of unintentional homicide and unintentionally causing injuries. 19. By a judgment of 3 June 1996, the Criminal Court found that the accused was entitled as of right to an amnesty under the Amnesty Law of 3 August 1995 in respect of the offence of unintentionally causing injuries entailing temporary unfitness for work of less than three months. As to the offence of unintentional homicide of the foetus, it held: “The issue before the Court is whether the offence of unintentional homicide or the unintentional taking of the foetus’s life is made out when the life concerned is that of a foetus – if a 20 to 21 week-old foetus is a human person (‘another’ within the meaning of Article 221-6 of the Criminal Code). ... The expert evidence must be accepted. The foetus was between 20 and 21 weeks old. At what stage of maturity can an embryo be considered a human person? The Voluntary Termination of Pregnancy Act of 17 January 1975 provides: ‘The law guarantees respect of every human being from the beginning of life.’ The Law of 29 July 1994 (Article 16 of the Civil Code) provides: ‘The law secures the primacy of the person, prohibits any assault on human dignity and guarantees the respect of every human being from the beginning of its life’. The laws of 29 July 1994 expressly employed the terms ‘embryo’ and ‘human embryo’ for the first time. However, the term ‘human embryo’ is not defined in any of them. When doing the preparatory work for the legislation on bioethics, a number of parliamentarians (both members of the National Assembly and senators) sought to define ‘embryo’. Charles de Courson proposed the following definition: ‘Every human being shall be respected from the start of life; the human embryo is a human being.’ Jean-François Mattéi stated: ‘The embryo is in any event merely the morphological expression of one and the same life that begins with impregnation and continues till death after passing through various stages. It is not yet known with precision when the zygote becomes an embryo and the embryo a foetus, the only indisputable fact being that the life process starts with impregnation.’ It thus appears that there is no legal rule to determine the position of the foetus in law either when it is formed or during its development. In view of this lack of a legal definition it is necessary to return to the known scientific facts. It has been established that a foetus is viable at 6 months and on no account, on present knowledge, at 20 or 21 weeks. The Court must have regard to that fact (viability at 6 months) and cannot create law on an issue which the legislators have not yet succeeded in defining. The Court thus notes that a foetus becomes viable at the age of 6 months; a 20 to 21 week-old foetus is not viable and is not a ‘human person’ or ‘another’ within the meaning of former Article 319 and Article 221-6 of the Criminal Code. The offence of unintentional homicide or of unintentionally taking the life of a 20 to 21 week-old foetus has not been made out, since the foetus was not a ‘human person’ or ‘another’... Acquits Dr G. on the charge without penalty or costs ...” 20. On 10 June 1996 the applicant appealed against that judgment. She argued that Dr G. had been guilty of personal negligence severable from the functioning of the public service and sought 1,000,000 French francs (FRF) in damages, comprising FRF 900,000 for the death of the child and FRF 100,000 for the injury she had sustained. The public prosecutor’s office, as second appellant, submitted that the acquittal should be overturned. It observed: “By failing to carry out a clinical examination, the accused was guilty of negligence that caused the death of the foetus, which at the time of the offence was between 20 and 24 weeks old and following, normally and inexorably, the path of life on which it had embarked, there being no medical doubt over its future.” 21. In a judgment of 13 March 1997, the Lyons Court of Appeal upheld the judgment in so far as it had declared the prosecution of the offence of unintentionally causing injuries time-barred but overturned the remainder of the judgment and found the doctor guilty of unintentional homicide. It imposed a six-month suspended prison sentence and a fine of FRF 10,000, holding: “... In the instant case Dr [G.]’s negligence is characterised in particular by the fact that the patient’s knowledge of French was insufficient to enable her to explain her condition to him, to answer his questions or to give him the date of her last period, circumstances that should have further impressed upon him the need for a thorough clinical examination. The assertion that he was entitled to rely on the medical records alone shows that, though an able scientist, this young doctor was nonetheless unaware of one of the essential skills of the practice of medicine: listening to, getting to know and examining the patient. Indeed, before this Court Dr [G.] said that the accident had impressed upon him how vital it was to take precautions before operating. There is a clear causal link between this negligent act and omission and the death of the child Mrs Vo was carrying. The accused has himself acknowledged, with commendable honesty, that a clinical examination would have alerted him to the fact that the patient was pregnant and had been mistaken for another patient. As regards the classification of the offence as unintentional homicide, it is first necessary to reiterate the legal principles governing this sphere. Various provisions of international treaties, such as Article 2 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, Article 6 of the International Covenant on Civil and Political Rights and Article 6 of the Convention on the Rights of the Child signed in New York on 26 January 1990, recognise a right to life protected by law for everyone, and notably children. Under domestic law, section 1 of the Voluntary Termination of Pregnancy Act (Law no. 75-17 of 17 January 1975) specifies: ‘The law guarantees respect of every human being from the beginning of life ... this principle may only be derogated from in the event of necessity and in accordance with the conditions set out in this statute.’ Further, Law no. 94-653 of 29 July 1994 on the respect of the human body lays down in Article 16 of the Civil Code: ‘The law secures the primacy of the person, prohibits any assault on human dignity and guarantees the respect of every human being from the beginning of its life.’ These statutory provisions cannot be regarded as mere statements of intent, devoid of any legal effect, since Article 16-9 of the Civil Code indicates that the provisions of Article 16 are mandatory. For its part the Criminal Division of the Court of Cassation applied these rules of international and domestic law in two judgments it delivered on 27 November 1996, specifying that the Act of 17 January 1975 only permits derogation from the rule stated in section 1 thereof that every human being is entitled to respect from the beginning of life in cases of necessity and subject to the conditions and limitations set out in it. The Court of Cassation added that, having regard to the conditions laid down by the legislature, the provisions of that statute and of the law of 31 December 1979 on the voluntary termination of pregnancy, taken as a whole, were not incompatible with the aforementioned treaty provisions. In a different case, moreover, the Court of Cassation pointed out that on signing the Convention on the Rights of the Child in New York on 26 January 1990, France made a declaration concerning interpretation in which it stated that the convention could not be interpreted as constituting any obstacle to the implementation of the provisions of French legislation on the voluntary termination of pregnancy. That reservation shows, by converse implication, that that convention could concern a foetus aged less than 10 weeks, the statutory maximum foetal age in France for a voluntary termination of pregnancy. It follows that, subject to the provisions on the voluntary termination of pregnancies and therapeutic abortions, the right to respect for every human being from the beginning of life is guaranteed by law, without any requirement that the child be born as a viable human being, provided it was alive when the injury occurred. Indeed, viability is a scientifically indefinite and uncertain concept, as the accused, who is currently studying in the United States, himself acknowledged, informing the Court that foetuses born between 23 and 24 weeks after conception could now be kept alive, a situation that was inconceivable a few years ago. In the opinion prepared by Professor [T.] and adduced in evidence by Dr [G.], reference is made to a report by Professor Mattéi in which it is indicated that the embryo is merely the morphological expression of one and the same life that begins with impregnation and continues till death after passing through various stages. It is not yet known with precision when the zygote becomes an embryo and the embryo a foetus, the only indisputable fact being that the life process starts with impregnation. ... Thus the issue of viability at birth, a notion that is uncertain scientifically, is in addition devoid of all legal effect, as the law makes no distinction on that basis. In the instant case it has been established that when the scan was performed on 27 November 1991 – before the amniotic fluid was lost later that day – the [applicant’s] pregnancy had been proceeding normally and the child she was carrying was alive. When the therapeutic abortion was performed on 5 December 1991, it was noted that a comparison of the child’s measurements with published tables suggested that the foetus was between 20 and 21 weeks old and possibly older, as it is not certain that the tables take into account the specific morphology of children of Vietnamese origin. Dr [G.], when questioned on this point at the hearing, was unable to provide any further information. The conclusion from the anatomo-pathological examination was that the foetal lung indicated an age of between 20 and 24 weeks, its measurements suggesting that an age at the lower end of that range was the most likely. In any event, as Dr [G.] said in evidence, the age of the foetus was very close to that of certain foetuses that have managed to survive in the United States. The photographs at page D 32 of the trial bundle show a perfectly formed child whose life was cut short by the accused’s negligence. As the Douai Court of Appeal observed in its judgment of 2 June 1987, had the assault on the child concerned inflicted a non-fatal wound, it would have been classified without any hesitation as an offence of unintentionally causing injuries. A fortiori, an assault leading to the child’s death must be classified as unintentional homicide. Thus, the strict application of the legal principles, established scientific fact and elementary common sense all dictate that a negligent act or omission causing the death of a 20 to 24 week-old foetus in perfect health should be classified as unintentional homicide. Consequently, the impugned judgment must be overturned ... While [the applicant’s] civil action is admissible, if only to corroborate the prosecution case, this Court has no jurisdiction to hear the claim for reparation. This is because despite the serious nature of the negligent act and omission of Dr [G.], a doctor in a public hospital, they do not constitute personal misconduct of such exceptional gravity entailing a total disregard for the most elementary principles and duties inherent in his function as to make them severable from public service. Nonetheless, it is appropriate to order Dr [G.] to pay to this civil party compensation in the sum of 5,000 francs under Article 475-1 of the Code of Criminal Procedure on account of costs which she has incurred, but which have not been paid by the State. ...” 22. On 30 June 1999, on an appeal on points of law by the doctor, the Court of Cassation reversed the judgment of the Lyons Court of Appeal and ruled that there was no reason to remit the case for retrial: “Having regard to Article 111-4 of the Criminal Code: Criminal-law provisions must be strictly construed. ... In convicting [the doctor] of unintentional homicide, the appellate court noted that Article 2 of the European Convention for the Protection of Human Rights and Fundamental Freedoms and Article 6 of the International Covenant on Civil and Political Rights recognise the existence for all persons of a right to life protected by law. The appellate court stated that the Voluntary Termination of Pregnancy Act of 17 January 1975 establishes the rule that the life of every human being must be respected from the beginning of life. That rule is now restated in Article 16 of the Civil Code as worded following the amendment made by the Law of 29 July 1994. The appellate court went on to state that, by operating without performing a prior clinical examination, the doctor was guilty of a negligent act or omission that had a definite causal link with the death of the child the patient was carrying. However, by so holding, when the matters of which the defendant was accused did not come within the definition of the offences set out in former Article 319 and Article 221-6 of the Criminal Code, the Court of Appeal misinterpreted the aforementioned provisions. ...” 23. The provision dealing with the unintentional taking of life at the material time and until 1 March 1994 was Article 319 of the Criminal Code, which read as follows: “Anyone who through his or her inadvertence, negligent act, inattention, negligent omission or breach of regulation unintentionally commits homicide or unintentionally causes death, shall be liable to imprisonment of between three months and two years and a fine of between 1,000 and 30,000 francs.” 24. Since 1 March 1994, the relevant provision has been Article 221-6 of the Criminal Code (as amended by Law no. 2000-647 of 10 July 2000 and Order no. 2000-916 of 19 September 2000), which is to be found in Section II (“Unintentional taking of life”) of Chapter I (“Offences against the life of the person”) of Part II (“Offences against the human person”) of Book II (“Serious crimes (crimes) and other major offences (délits) against the person”). Article 221-6 provides: “It shall be an offence of unintentional homicide punishable by three years’ imprisonment and a fine of 45,000 euros to cause the death of another in the conditions and in accordance with the distinctions set out in Article 121-3 by inadvertence, negligent act, inattention, negligent omission or breach of a statutory or regulatory duty of safety or care. In the event of a manifestly deliberate breach of a special statutory or regulatory duty of safety or care, the maximum sentences shall be increased to five years’ imprisonment and a fine of 75,000 euros.” 25. Article 223-10 of the Criminal Code, which concerns the voluntary termination of pregnancy by a third party without the mother’s consent, is to be found in Section V under the heading “Unlawful termination of pregnancy” of Chapter III, entitled “Endangering the person”, in Part II of Book II. It reads as follows: “It shall be an offence punishable by five years’ imprisonment and a fine of 75,000 euros to terminate a pregnancy without the mother’s consent.” 26. Section III entitled “Protection of the human embryo” of Chapter I (“Offences against biomedical ethics”) of Part I (“Public-health offences”) of Book V (“Other serious crimes (crimes) and other major offences (délits)”) prohibits various types of conduct on grounds of medical ethics (Articles 511-15 to 511-25), including the conception of human embryos in vitro for research or experimental purposes (Article 511-18). 27. At the material time the limitation period for an action in damages in the administrative courts was four years, while the period in which a pregnancy could be voluntarily terminated lawfully was ten weeks following conception. 28. The provisions of the Public Health Code as worded since the Patients’ Rights and Quality of the Health Service Act (Law no. 2002-303 of 4 March 2002) came into force read as follows: “Save where they incur liability as a result of a defect in a health product, the medical practitioners mentioned in Part IV of this Code and all hospitals, clinics, departments and organisations in which preventive medicine, diagnosis or treatment is performed on individuals shall only be liable for damage caused by preventive medicine, diagnosis or treatment if they have been at fault. ...” “Private medical practitioners, the hospitals, clinics, health services and organisations mentioned in Article L. 1142-1 and any other legal entity other than the State that is engaged in preventive medicine, diagnosis or treatment and the producers and suppliers of and dealers in health products in the form of finished goods mentioned in Article L. 5311-1 with the exception of sub-paragraph 5 thereof, subject to the provisions of Article L. 1222-9, and sub-paragraphs 11, 14 and 15, that are used in connection with such activities shall be under a duty to take out insurance in respect of any third-party or administrative liability they may incur for damage sustained by third parties as a result of an assault against the person in the course of that activity taken as a whole. ...” “The limitation period for actions against medical practitioners and public or private hospitals or clinics in respect of preventive medicine, diagnosis or treatment shall be ten years from the date the condition stabilises.” “As stated in Article 16 of the Civil Code as hereafter reproduced: ‘ ‘The law secures the primacy of the person, prohibits any assault on human dignity and guarantees the respect of every human being from the beginning of its life.’ ” “The principle referred to in Article L. 2211-1 may only be derogated from in the event of necessity and in accordance with the conditions set out in this Part. It shall be the nation’s duty to educate society on this principle and its consequences, [to provide] information on life’s problems and on national and international demography, to inculcate a sense of responsibility, to receive children into society and to uphold family life. The State, aided by the local and regional authorities, shall perform these obligations and support initiatives that assist it to do so.” “A pregnant woman whose condition causes her distress may ask a doctor to terminate her pregnancy. The pregnancy may only be terminated within the first twelve weeks.” “A pregnancy may be voluntarily terminated at any time if two doctors from a pluridisciplinary team certify, after the team has issued a consultative opinion, that either the woman’s continued pregnancy puts her health at serious risk or that it is highly likely that the unborn child is suffering from a particularly serious affection which is recognised as incurable at the time of diagnosis. ...” 29. The Court of Cassation has followed its decision in the instant case (see paragraph 22 above) on two occasions (in its judgments of 29 June 2001 (full court), Bulletin no. 165, and of 25 June 2002 (Criminal Division), Bulletin no. 144), despite submissions from the advocates-general concerned to the contrary. “As regards the two grounds of appeal of the public prosecutor at the Metz Court of Appeal and of Mrs X which have been joined together ... : On 29 July 1995 a vehicle being driven by Mr Z collided with a vehicle being driven by Mrs X, who was six months pregnant. She was injured and as a result of the impact lost the foetus she was carrying. In the impugned judgment (Metz Court of Appeal, 3 September 1998), Mr Z was convicted of unintentionally injuring Mrs X, aggravated by the fact that he was under the influence of drink. However, he was acquitted of the unintentional killing of the unborn child. The grounds of appeal against that decision are, firstly, that Article 221-6 of the Criminal Code, which makes it an offence to cause the death of another, does not exclude from its scope a viable unborn child and that, by holding that this provision applied only to a child whose heart was beating at birth and who was breathing, the Court of Appeal had added a condition that was not contained in the statute, and, secondly, unintentionally causing the death of an unborn child constituted the offence of unintentional homicide if the unborn child was viable at the material time, irrespective of whether or not it breathed when it was separated from the mother, with the result that there had been a violation of Articles 111-3, 111-4 and 221-6 of the Criminal Code and Article 593 of the Code of Criminal Procedure. The rule that offences and punishment must be defined by law, which requires that criminal statutes be construed strictly, pleads against extending the scope of Article 221-6 of the Criminal Code, which makes unintentional homicide an offence, to cover unborn children whose status in law is governed by special provisions concerning embryos and foetuses. ...” “... Having regard to former Article 319, Article 221-6 and Article 111-4 of the Criminal Code: The rule that offences and punishment must be defined by law, which requires that criminal statutes be construed strictly, pleads against a charge of unintentional homicide lying in the case of a child that is not born alive. The impugned judgment established that Z, whose pregnancy under the supervision of X came to term on 10 November 1991, attended the clinic in order to give birth on 17 November. She was placed under observation at about 8.30 p.m. and drew the attention of the midwife, Y, to an anomaly in the child’s cardiac rhythm. Y refused to call the doctor. A further test carried out at 7 a.m. the following morning showed a like anomaly and subsequently that the heart had stopped beating altogether. At about 8 a.m., X pronounced the baby dead. In the evening he proceeded to extract the stillborn child by caesarean section. According to the autopsy report, the child did not present any malformation but had suffered from anoxia. In finding Y guilty of unintentional homicide and X, who was acquitted by the Criminal Court, liable for the civil consequences of that offence, the Court of Appeal held that the child’s death was a result of the negligent acts and omissions of both the doctor in failing to place the patient, who was beyond term, under closer observation and of the midwife in failing to notify an unequivocal anomaly noted when the child’s cardiac rhythm was recorded. After noting that the stillborn child did not present any organic lesion capable of explaining its death, the Court of Appeal stated: ‘This child had reached term several days previously and, but for the fault that has been found, would have been capable of independent survival, with a human existence separate from its mother’s.’ However, by so holding, the Court of Appeal misapplied the provisions referred to above and the aforementioned principles. It follows that this appeal on points of law is allowed. The case will not be remitted, as the facts are not capable of coming within the definition of any criminal offence. ...” 30. The Criminal Division of the Court of Cassation has held that a court of appeal gave valid reasons for finding a defendant guilty of the unintentional homicide of a child who died an hour after its birth on the day of a road traffic accident in which its mother, who was eight months’ pregnant, was seriously injured, when it held that, by failing to control his vehicle, the driver had caused the child’s death an hour after birth as a result of irreversible lesions to vital organs sustained at the moment of impact (Court of Cassation, Criminal Division, 2 December 2003). 31. An article entitled “Unintentional violence on pregnant women and the offence of unintentional homicide” (Recueil Dalloz 2004, p. 449) notes that in twenty-eight out of a total of thirty-four articles commenting on the Criminal Division of the Court of Cassation’s judgment of 2 December 2003 (see paragraph 30 above) the authors are critical of the Court of Cassation’s case-law (see paragraph 29 above). The criticism includes: the laconic reasoning of the Court of Cassation’s judgments and incoherence of the protection afforded, as a person causing unintentional injury is liable to criminal prosecution while a person who unintentionally causes the death of the foetus goes unpunished; the fact that a child who has lived for a few minutes is recognised as having standing as a victim, whereas a child that dies in utero is ignored by the law; and the fact that freedom to procreate is less well protected than freedom to have an abortion. 32. On 27 November 2003 the National Assembly adopted on its second reading a bill to adapt the criminal justice system to changes in criminality. The bill included the Garraud amendment, so named after the member of parliament who introduced it, which created an offence of involuntary termination of pregnancy (ITP). 33. The adoption of this amendment gave rise to fierce controversy and, after a week of consultations, the Minister of Justice, Mr Perben, declared on 5 December 2003 that the member’s proposal “caused more problems than it solved” and that he was in favour of abandoning it. On 23 January 2004 the Senate unanimously deleted the amendment. This was the second time the senators had rejected such a proposal, as they had already opposed it in April 2003 when examining the Reinforcement of Protection against Road Violence Act, passed on 12 June 2003. 34. On 11 December 2003 the National Assembly adopted on its second reading a bill on bioethics with a view to reforming the 1994 laws on the donation and use of parts and products of the human body, medically assisted procreation and prenatal diagnosis, as envisaged by the legislature at the time, in order to take into account subsequent scientific and medical progress and new issues with which society was confronted. In view of the speed with which technological advances are made, the bill reinforces the guarantees on the provision of information and on seeking and obtaining consent, prohibits certain practices that are technically feasible (reproductive cloning) and provides a framework for those with a proven medical interest (research on embryos in vitro). It establishes a regulatory and supervisory body (the Procreation, Embryology and Human Genetics Agency) whose functions also include acting as a watchdog and providing support and expert guidance in these spheres (http://www.assemblee-nationale.fr/dossiers/bioethique.asp). 35. The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also known as the Convention on Human Rights and Biomedicine, which was opened for signature on 4 April 1997 in Oviedo, came into force on 1 December 1999. In this convention, the member States of the Council of Europe, the other States and the European Community signatories to it, “... Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine, ... agreed as follows: Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine. Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention. The interests and welfare of the human being shall prevail over the sole interest of society or science. ... ... 1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. 2. The creation of human embryos for research purposes is prohibited. ... The European Court of Human Rights may give, without direct reference to any specific proceedings pending in a court, advisory opinions on legal questions concerning the interpretation of the present Convention at the request of: – the Government of a Party, after having informed the other Parties; – the Committee set up by Article 32, with membership restricted to the Representatives of the Parties to this Convention, by a decision adopted by a two-thirds majority of votes cast. ...” 36. The commentary on Article 1 (see paragraphs 16 to 19 of the explanatory report on the convention) states: “16. This Article defines the Convention’s scope and purpose. 17. The aim of the Convention is to guarantee everyone’s rights and fundamental freedoms and, in particular, their integrity and to secure the dignity and identity of human beings in this sphere. 18. The Convention does not define the term ‘everyone’ (in French ‘toute personne’). These two terms are equivalent and found in the English and French versions of the European Convention on Human Rights, which however does not define them. In the absence of a unanimous agreement on the definition of these terms among member States of the Council of Europe, it was decided to allow domestic law to define them for the purposes of the application of the present Convention. 19. The Convention also uses the expression ‘human being’ to state the necessity to protect the dignity and identity of all human beings. It was acknowledged that it was a generally accepted principle that human dignity and the identity of the human being had to be respected as soon as life began. ...” 37. Article 1 of the Protocol provides: “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.” 38. The draft Protocol was approved by the Steering Committee on Bioethics on 20 June 2003. It was submitted for approval to the Committee of Ministers of the Council of Europe, which sought a consultative opinion from the Parliamentary Assembly. On 30 April 2004 the Assembly issued an opinion (no. 252 (2004)) in which it declared itself in favour of the draft Protocol. On 30 June 2004 the Committee of Ministers adopted the text. “Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research involving interventions on human beings in the field of biomedicine.” “1. This Protocol covers the full range of research activities in the health field involving interventions on human beings. 2. This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and embryos in vivo. ...” “The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science.” “1. Research on a pregnant woman which does not have the potential to produce results of direct benefit to her health, or to that of her embryo, foetus or child after birth, may only be undertaken if the following additional conditions are met: (i) the research has the aim of contributing to the ultimate attainment of results capable of conferring benefit to other women in relation to reproduction or to other embryos, foetuses or children; ...” The explanatory report repeats the terms of the explanatory report on the convention. 39. The Working Party on the Protection of the Human Embryo and Foetus set up by the Steering Committee on Bioethics reached the following conclusion in a report drawn up in 2003: “This report aimed at giving an overview of current positions found in Europe regarding the protection of the human embryo in vitro and the arguments supporting them. It shows a broad consensus on the need for the protection of the embryo in vitro. However, the definition of the status of the embryo remains an area where fundamental differences are encountered, based on strong arguments. These differences largely form the basis of most divergences around the other issues related to the protection of the embryo in vitro. Nevertheless, even if agreement cannot be reached on the status of the embryo, the possibility of re-examining certain issues in the light of the latest developments in the biomedical field and related potential therapeutic advances could be considered. In this context, while acknowledging and respecting the fundamental choices made by the different countries, it seems possible and desirable with regard to the need to protect the embryo in vitro on which all countries have agreed, that common approaches be identified to ensure proper conditions for the application of procedures involving the creation and use of embryos in vitro. The purpose of this report is to aid reflection towards that objective.” 40. The Group has issued, inter alia, the following opinion on the ethical aspects of research involving the use of human embryos in the context of the 5th Framework Programme (23 November 1998): “... Legal background Controversies on the concept of beginning of life and ‘personhood’ Existing legislation in the Member States differs considerably from one another regarding the question of when life begins and about the definition of ‘personhood’. As a result, no consensual definition, neither scientifically nor legally, of when life begins exists. Two main views about the moral status of the embryo and thus regarding the legal protection afforded to them with respect to scientific research exist: (i) human embryos are not considered as human beings and consequently have a relative worth of protection; (ii) human embryos have the same moral status as human beings and consequently are equally worthy of protection. The discussion of common rules on embryo research is continuing. Recently many European countries, when discussing and signing the Council of Europe Convention on Human Rights and Biomedicine, failed to reach a consensus concerning the definition of the embryo, and, therefore, were unable to find common ground on which to place the admissibility of human embryo research within the Convention. Hence, it is up to the Member States to legislate in this area. Yet, nevertheless, Article 18.1 of the Convention stipulates ‘where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo’. ... Different approaches regarding the definition of the human embryo In most Member States there is presently no legal definition of the human embryo (Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal and Sweden). Among those Member States which define the embryo in their legislation, the existing definitions vary considerably from one country to another (Austria, Germany, Spain and the United Kingdom) ... ... Different scope of national legislation Among the Member States with legal provisions on embryo research, there are many differences regarding the activities allowed and prohibited. There are countries where embryo research is allowed only for the benefit of the particular embryo (Austria, Germany). There are Member States where embryo research is exceptionally allowed (France, Sweden), or allowed under strict conditions (Denmark, Finland, Spain, United Kingdom). ... Diversity of views The diversity of views regarding the question whether or not research on human embryos in vitro is morally acceptable, depends on differences in ethical approaches, philosophical theories and national traditions, which are deeply rooted in European culture. Two contrasting approaches exist: a deontological approach, in which duties and principles control the ends and consequences of our actions; and utilitarian or consequentialist approaches in which human actions are evaluated in terms of means and ends or consequences. ... The group submits the following opinion In the preamble it appeared crucial to recall that the progress of knowledge of life sciences, which in itself has an ethical value, cannot, in any case, prevail over fundamental human rights and the respect which is due to all the members of the human family. The human embryo, whatever the moral or legal status conferred upon it in the different European cultures and ethical approaches, deserves legal protection. Even if taking into account the continuity of human life, this protection ought to be reinforced as the embryo and the foetus develop. The Treaty on European Union, which does not foresee legislative competence in the fields of research and medicine, implies that such protection falls within the competence of national legislation (as is the case for medically assisted procreation and voluntary interruption of pregnancy). However, Community authorities should be concerned with ethical questions resulting from medical practice or research dealing with early human development. However, when doing so, the said Community authorities have to address these ethical questions taking into account the moral and philosophical differences, reflected by the extreme diversity of legal rules applicable to human embryo research, in the 15 Member States. It is not only legally difficult to seek harmonisation of national laws at Community level, but because of lack of consensus, it would be inappropriate to impose one exclusive moral code. The respect for different philosophical, moral or legal approaches and for diverse national culture is essential to the building of Europe. From an ethical point of view, the multicultural character of European society requires mutual tolerance to be shown by the citizens and political figures of the European Nation States that have chosen uniquely to tie their destiny together, while at the same time ensuring mutual respect for different historical traditions which are exceedingly strong. From a legal point of view, this multiculturalism is based upon Article 6 of the Amsterdam Treaty (ex Article F of the Treaty on European Union) which recognises fundamental rights at Union level notably based on ‘constitutional traditions common to the Member States’. It also declares that ‘the Union shall respect the national identity of its Member States’. It results from the aforementioned principles, that, in the scope of European research programmes, the question of research on the human embryo has to be approached, not only with regard to the respect for fundamental ethical principles, common to all Member States, but equally taking into consideration diverse philosophical and ethical conceptions, expressed through the practices and the national regulations in force in this field. ...” 41. In the majority of the member States of the Council of Europe, the offence of unintentional homicide does not apply to the foetus. However, three countries have chosen to create specific offences. In Italy a person who negligently causes a pregnancy to terminate is liable to a prison sentence of between three months and two years under section 17 of the Abortion Act of 22 May 1978. In Spain Article 157 of the Criminal Code makes it a criminal offence to cause damage to the foetus and Article 146 an offence to cause an abortion through gross negligence. In Turkey Article 456 of the Criminal Code lays down that a person who causes damage to another shall be liable to a prison sentence of between six months and one year; if the victim is a pregnant woman and the damage results in premature birth, the Criminal Code prescribes a sentence of between two and five years’ imprisonment.