CEDH · CASELAW;JUDGMENTS;GRANDCHAMBER;ENG — 17 septembre 2024

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SPAIN (Application no. 15541/20)   JUDGMENT   Art 8 read in light of Art 9 • Private life • Medical treatment in the form of blood transfusions administered to a Jehovah’s Witness, during emergency surgery, despite her expressed refusal to undergo a blood transfusion of any kind • Competent adult patients free to decide on surgery or medical treatment, including blood transfusion • Need for robust legal and institutional safeguards in decision-making process • Elucidation of procedural requirements applicable to decision-making process • Decision to refuse life-saving treatment must be clear, specific and unambiguous and represent the patient’s current position on the matter • In the event of doubt, health care professionals under a duty to make every reasonable effort to determine patient’s wishes • When in an emergency, despite efforts to dispel doubts, reasonable grounds exist to doubt an individual’s decision to refuse life-saving treatment, proceeding with such treatment cannot be considered a failure to respect his or her personal autonomy •   In life-threatening situations, the right to life arises in tandem with an individual’s right to decide autonomously on medical treatment • No European consensus in relation to the modalities for reconciling those two rights by taking into account a patient’s previously expressed wishes • Principle of giving binding legal effect to advance directive and related formal and practical modalities within a State’s margin of appreciation • Need for a system of advance medical directives relied on by patients to function effectively   •   Well-developed domestic framework, in conformity with the Oviedo Convention, for ensuring respect for patient autonomy in the domestic health system • Shortcomings in decision-making process in the present case did not afford sufficient respect for the applicant’s autonomy • Failure to provide duty judge with an adequate factual basis of the decision regarding applicant’s refusal of treatment recorded in writing in various forms and at various times   • Lack of essential and accurate information had a   determinative effect on the duty-judge’s decision-making • Failure to take into account applicant’s decision-making capacity • Shortcomings not remedied by the Higher Courts   Prepared by the Registry. Does not bind the Court.     STRASBOURG 17 September 2024   This judgment is final but it may be subject to editorial revision.   Table of Contents INTRODUCTION PROCEDURE THE FACTS THE CIRCUMSTANCES OF THE CASE A.   Treatment of the applicant at Soria hospital B.   Transfer of the applicant to La Paz hospital C.   Application by La Paz doctors to the duty judge D.   Treatment of the applicant at La Paz hospital E.   The ensuing proceedings 1.   Initial examination of the applicant’s appeal 2.   Proceedings before the Audiencia Provincial 3.   The applicant’s appeal to the Constitutional Court 4.   Provision to the applicant of the signed informed consent document RELEVANT LEGAL FRAMEWORK AND PRACTICE I.   DOMESTIC LAW AND PRACTICE A.   Spanish Constitution B.   State legislation C.   Regional legislation D.   Relevant domestic case-law 1.   Constitutional Court (a)   Judgment 120/1990 of 27 June 1990 (b)   Judgment 37/2011 of 28 March 2011 (c)   Judgment 19/2023 of 25 April 2023 (d)   Judgment 44/2023 of 9 May 2023 2.   From the ordinary courts (a)   Audiencia Provincial of Guipúzcoa (Section 2), appeal no. 2086/2004, Decision of 22 September 2004 (b)   Audiencia Provincial of Lleida (Section 1), appeal no. 440/2010, Decision no.   28/2011 of 25 January 2011 II.   RELEVANT INTERNATIONAL MATERIALS A.   Council of Europe 1.   The Convention on Human Rights and Biomedicine – the Oviedo Convention 2.   Text adopted by the Committee of Ministers 3.   Text adopted by the Parliamentary Assembly 4.   Guide on the decision-making process regarding medical treatment in end ‑ of-life situations B.   European Union C.   United Nations D.   Other relevant materials III.   COMPARATIVE LAW THE LAW I.   ALLEGED VIOLATIONS OF ARTICLES 8 AND 9 OF THE CONVENTION A.   Admissibility 1.   The parties’ submissions (a)   The Government (b)   The applicant 2.   The Court’s assessment B.   Merits 1.   Legal characterisation of the case 2.   The parties’ submissions (a)   The applicant (b)   The Government (c)   The third parties (i)   The European Association of Jehovah’s Witnesses (ii)   The French Government 3.   The Court’s assessment (a)   Preliminary observations (b)   The interference with the applicant’s right to respect for private life (c)   Justification for the interference (i)   Lawfulness of the interference (ii)   Aim of the interference (iii)   Necessity of the interference (α)   Relevant case-law principles ‒   On personal autonomy in the sphere of health care ‒   On the duty of the State to protect the life and health of patients ‒   On procedural safeguards (β)   Reconciling the Convention rights and duties at stake ‒   Previously expressed wishes of the patient (γ)   Application of the above principles and considerations to the present case ‒   Safeguards under the domestic legal framework ‒   The application to the duty judge ‒   The consideration of the application by the duty judge ‒   The terms of the decision ‒   The implementation of the decision ‒   The review of the decision ‒   Overall assessment of the decision-making process ‒   Conclusion II.   APPLICATION OF ARTICLE   41 OF THE CONVENTION A.   Damage B.   Costs and expenses OPERATIVE PROVISIONS CONCURRING OPINION OF JUDGE ELÓSEGUI CONCURRING OPINION OF JUDGE KTISTAKIS, JOINED BY JUDGE MOUROU-VIKSTRÖM PARTLY CONCURRING AND PARTLY DISSENTING OPINION OF JUDGE SEIBERT-FOHR, JOINED BY JUDGES KUCSKO-STADLMAYER, PASTOR VILANOVA, RAVARANI, KŪRIS, LUBARDA, KOSKELO AND BORMANN     In the case of Pindo Mulla v. Spain, The European Court of Human Rights, sitting as a Grand Chamber composed of:   Síofra O’Leary, President ,   Marko Bošnjak,   Gabriele Kucsko-Stadlmayer,   Pere Pastor Vilanova,   Arnfinn Bårdsen,   Georges Ravarani,   Egidijus Kūris,   Branko Lubarda,   Mārtiņš Mits,   Stéphanie Mourou-Vikström,   Pauliine Koskelo,   María Elósegui,   Anja Seibert-Fohr,   Ioannis Ktistakis,   Frédéric Krenc,   Mykola Gnatovskyy,   Anne Louise Bormann , judges , and Marialena Tsirli, Registrar, Having deliberated in private on 10 January 2024 and on 19 June 2024, Delivers the following judgment, which was adopted on the latter date: INTRODUCTION 1.     This case concerns the response of the authorities to the refusal of medical treatment in the form of blood transfusions by an adult patient under the public health system of a Contracting Party. The applicant is a Jehovah’s Witness who complained that in the course of emergency surgery she was given transfusions despite having previously stated her rejection of this procedure, a stance inspired by her religious beliefs. Before the Court she raised complaints under Articles 8 and 9 of the Convention for the Protection of Human Rights and Fundamental Freedoms (“the Convention”). PROCEDURE 2.     The case originated in an application (no. 15541/20) against the Kingdom of Spain lodged with the Court under Article   34 of the Convention by an Ecuadorian national, Ms Rosa Edelmira Pindo Mulla (“the applicant”), on 13 March 2020. 3.     The applicant was represented by Mr P. Muzny, a lawyer based in Switzerland. The Spanish Government (“the Government”) were represented by their Agent, Mr A. Brezmes Martínez de Villarreal. 4.     The application was allocated to the Fifth Section of the Court, pursuant to Rule 52 § 1 of the Rules of Court. On 16 April 2021, the Government were given notice of the applicant’s complaints relating to her right to respect for private life and her right to freedom of religion, raised under Articles 8 and 9 of the Convention respectively. The remainder of the application was declared inadmissible pursuant to Rule   54   §   3. 5.     On 4 July 2023, a Chamber of the Fifth Section decided to relinquish jurisdiction in favour of the Grand Chamber (Article 30 of the Convention and Rule   72). 6.     The composition of the Grand Chamber was determined according to the provisions of Article   26 §§   4 and   5 of the Convention and Rule   24 of the Rules of Court. During the second deliberations, Georges Ravarani and Egidijus Kūris, whose terms of office expired in the course of the proceedings, continued to deal with the case   (Article 23 § 2 of the Convention and Rule 24 § 4). 7.     The President of the Grand Chamber granted leave to intervene in the proceedings to the European Association of Jehovah’s Witnesses, as well as to the French Government, both of whom submitted written comments (Article 36 § 2 of the Convention and Rule 44 § 3). 8.     A hearing took place in public in the Human Rights Building, Strasbourg, on 10 January 2024.   There appeared before the Court: (a)     for the Government Mr A. Brezmes Martínez de Villarreal ,   Agent , Ms H. Nicolás Martínez ,   Co-Agent , Mr F. Sanz Gandasegui ,           Counsel , Mr F. Reinoso Barbero , Ms F. Molina Agea , and Ms A. Domínguez Bravo ,   Advisers; (b)     for the applicant Mr P. Muzny , Mr S. Brady , and Mr D. García Martín ,   Counsel .   The applicant also attended the hearing. The Court heard addresses by Ms Nicolás Martínez, Mr Brezmes Martínez de Villarreal, Mr Muzny and Mr Brady. It also heard their replies, and that of Mr   Reinoso Barbero, to questions put by judges. THE FACTS THE CIRCUMSTANCES OF THE CASE A.    Treatment of the applicant at Soria hospital 9.     The applicant was born in 1970 and lives in Soria, located in the Autonomous Community of Castile and Leon, Spain. 10.     In May 2017 she was treated as an outpatient at the Santa Bárbara hospital at Soria (hereafter “the Soria hospital”), a public hospital run by the Autonomous Community of Castile and Leon, for a problem of urinary retention. Medical testing carried out over the following two months established that her complaint was due to the presence of a uterine fibroid (myoma). The applicant was advised to have surgery to remove it (hysterectomy and double salpingectomy). According to the applicant, she agreed with this advice while also informing the Soria hospital of her refusal of blood transfusion, based on the teachings of her religious community. 11.     On 4 August 2017, and in view of the prospect of surgery, the applicant drew up two documents setting out her refusal of blood transfusion. In accordance with the relevant statutory provision – Article 11 of Act   No.   41/2002 (see further under “Domestic law and practice” below) – she drew up an advance medical directive ( documento de instrucciones previas ), which provided as relevant (emphasis in the original): “Acting freely and with full capacity, having received sufficient information and after having carefully reflected, I have come to the decision to express through this document the following advance directive regarding care and treatment, that I desire to be taken into account for my medical care if I come to be in a situation in which I cannot express my will [...]. I DECLARE That I formulate this advance medical directive with full moral conviction and under the protection of current legislation. I am one of Jehovah’s Witnesses, and I obey the Biblical command to ‘abstain from blood’ (Acts 15:28,29). This is my firm religious conviction that I have freely adopted in agreement with my conscience. That this advance medical directive expresses my informed decision regarding the medical treatment that I want to be taken into account in all healthcare situations . Having been informed of the dangers and risks associated with blood and blood product transfusions, I have decided to avoid them and accept the risks that may derive from my choice of non-blood alternative treatments. I DIRECT that no transfusions of whole blood, red cells, white cells, platelets or plasma be given to me under any circumstances, even if health-care providers consider that such are necessary to preserve my life or my health. However, I accept non-blood expanders of plasma volume and all medical treatment that does not involve the use of blood.” 12.     The applicant appointed two trusted friends as her representative and substitute representative, Mr A.G.J and Mr R.A.L. respectively. Their addresses and telephone numbers were included in the document. The role and remit of the representative were stated as follows (emphasis in the original): “In case of total or partial, temporal or permanent loss of my decision-making capacity, I appoint the person named herein as my representative. The person appointed as my representative shall make any interpretation that may be necessary on my behalf, as long as it does not contradict any of the instructions recorded in this document, and will ensure the application of its content. This person should be considered as a necessary and valid interlocutor with the health care team in charge of my care to make decisions in my name, to be responsible for my care and to ensure that my wishes are honoured.” 13.     The applicant’s signature on the advance directive was witnessed by three witnesses, in keeping with the formalities provided for by law. On the same day, she deposited her advance directive with the Register of Advance Directives of Castile and Leon. Following this, the document was accessible to Soria hospital via the electronic system used by health professionals in Castile and Leon (known as “Jimena”). For reasons unknown to the Court, it was not physically added to her medical file at Soria hospital. 14.     The second document was a continuing power of attorney ( declaración de voluntades anticipadas ), in which she expressed her refusal of blood transfusion in terms similar to those used in her advance medical directive and appointed the same persons as her healthcare representative and substitute. It was signed by the applicant and counter-signed by three witnesses. The applicant indicated that she carried this document with her. 15.     In December 2017, the applicant attended a private clinic, where the presence of a uterine myoma was confirmed. 16.     At the beginning of January 2018, the applicant returned to the emergency department of the Soria hospital complaining of vaginal bleeding and spells of dizziness. Following examination and tests, she was prescribed medication to stop the bleeding (tranexamic acid) and to reduce the size of the myoma (ulipristal acetate). As she was anaemic (haemoglobin of   7.7   g/dL), she was also prescribed iron. Her previous agreement to undergo surgery was noted in her medical file. According to the applicant, she followed this course of medication until the month of June. 17.     On 5 June 2018, the applicant went to the emergency department of the Soria hospital complaining of bleeding and abdominal pain. A blood test done that day measured her haemoglobin at 12.2 g/dL. She was discharged the same day but returned the following day on account of further bleeding. This time she was admitted to the hospital’s obstetrics and gynaecology service. Blood tests carried out that day measured her haemoglobin at   8.9   g/dL and later at 6.5 g/dL. It was established by ultrasound and CT scan that the myoma had become very large. 18.     Late on 6 June, a gynaecologist, Dr B.L., spoke to the applicant about receiving a blood transfusion, which the applicant refused. She expressed her refusal in writing on the hospital’s informed consent document, which she signed as did Dr B.L. This document became part of the applicant’s medical file at Soria hospital. 19.     The following day, 7 June 2018, Dr A. F., a haematologist, noted in a medical report that the applicant was suffering from severe anaemia, referring to a decrease in her haemoglobin from 12.2g/dL the previous day to   5.7 g/dL around midnight and to 4.7 g/dL by that morning. He observed that the decrease seemed to have attenuated. He noted in the report: “The patient for religious reasons (Jehovah’s Witness) does not wish to be transfused under any circumstances. I inform the patient of possible life-threatening seriousness in case in any circumstance the bleeding worsens again, and she consciously refuses any transfusion.” The report further noted that treatment with tranexamic acid appeared to have been effective. The doctor explained that he was modifying the treatment in order to stop the bleeding and recover haemoglobin levels. 20.     By around 11.00 on the morning of 7 June 2018 the decision had been taken to transfer the applicant to La Paz hospital in Madrid, situated in a different Autonomous Community, an establishment that is known for its capacity to provide forms of treatment that do not involve blood transfusions. In a discharge report drawn up by Dr B. L, the following appears (capitalisation in the original): “We propose BLOOD TRANSFUSION BUT THE PATIENT REFUSES (SIGNS INFORMED CONSENT indicating that she does not accept blood transfusion, Jehovah’s Witness patient). Given the clinical situation and the impossibility of performing blood transfusion, it was decided to transfer to the Referral Hospital with Interventional Radiology to assess uterine artery embolization treatment.” [1] The patient history report notes that there was little bleeding at 7.40 a.m., and no bleeding at 9.14 a.m. or at 12.12 p.m., when the applicant was prepared for transfer. 21.     The applicant agreed to the transfer to La Paz, her understanding being that she could be treated there without resort to blood transfusion. B.    Transfer of the applicant to La Paz hospital 22 .     The applicant was transferred by mobile intensive care ambulance with a doctor on board to monitor her condition during the journey to Madrid, a distance of approximately 240 km. The applicant was on board the ambulance by 12.12   p.m. Her medical records were brought with her, but at no point in these proceedings was the Court informed of what those medical records contained. She was not accompanied by any member of her family; her husband travelled separately to La Paz by car. 23.     Shortly after the journey began, there was telephone contact between a doctor at La Paz and the doctor on board the ambulance, the latter warning of the gravity of the applicant’s condition and referring to the probability that she would be in a state of circulatory collapse or even cardiac arrest by the time the ambulance arrived. The applicant informed the doctor at La Paz of her position regarding blood transfusion. 24.     The applicant’s condition was monitored throughout the journey. It was recorded that her bleeding at that stage was limited (less than menstrual bleeding). It was also recorded that she was conscious, orientated and cooperative. C.    Application by La Paz doctors to the duty judge 25.     At 12.36 p.m., a fax was sent in the name of three La Paz doctors to the duty judge ( juez de guardia ) of Investigating Court ( Juzgado de Instrucción ) No. 9 of Madrid. The message read as follows: “Good morning, we are anaesthesiologists at the La Paz Hospital in Madrid, and today, 7 June 2018, we have just been informed that a Jehovah’s Witness patient will be transferred from the hospital in Soria. The patient has active bleeding due to her myomatous uterus and she is being transferred with a 4 gr/dl. haemoglobin level. The patient in Soria has verbally expressed her rejection of all types of treatment. The patient is on her way, and we want to know how to proceed since the patient will be very unstable upon arrival. Please reply as soon as possible.” 26.     The duty judge requested an opinion on the doctors’ request from the forensic doctor ( médico forense ) assigned to Investigating Court No. 9. The forensic doctor’s opinion, which was based solely on the information provided in the fax, stated: “The medical report describes the situation of a patient (whose identity is unknown) who is being transferred from the hospital in Soria on account of active bleeding due to her myomatous uterus with a haemoglobin level of 4   g/dl. The patient in Soria has verbally expressed her refusal of all types of treatment, as stated in the report. Although for now it is unknown whether the patient is in a position to grant and/or refuse her consent, as well as the nature of the treatment that she will be submitted to, it can be said that if the patient’s haemorrhage persists and in view of her haemoglobin levels, the situation poses a serious risk to the patient’s life.” 27.     The duty judge also contacted the local prosecutor ( Ministerio Fiscal ). The reply received referred to the forensic doctor’s warning that a failure to treat the applicant could lead to a fatal outcome and noted that there was an absence of “any reliable evidence” of a refusal on the applicant’s part to receive medical treatment. It stated that, with the aim of safeguarding the supreme legal value of the right to life, the prosecutor was not opposed to the necessary medical and surgical measures being taken to safeguard the life and physical integrity of the applicant. 28 .     The duty judge’s decision ( auto ) on the matter was transmitted by fax to La   Paz hospital at 1.36 pm. It stated, as relevant: “FIRST. According to the legal doctrine established by the judgment issued by the plenary formation of the Constitutional Court on 27 June 1990 [2] [...], the fundamental right to life, as a subjective right, grants its holders the possibility to seek judicial protection against any action by the public authorities that may threaten their life or integrity. On the other hand, as one of the objective fundamentals of the legal order, it also imposes upon the public authorities the duty of taking the necessary measures to protect those legal values, [ namely ] life and physical integrity, against attacks by third parties, disregarding the will of the right holders ... The content of the right to life comprises positive protection that prevents its interpretation as a freedom including the right to one’s own death. Article 16 of the Spanish Constitution does not grant the right to religious freedom without any type of limitation. Inherent in the right to religious freedom is the limitation of that right where it collides with other fundamental rights. SECOND. In this case, the information provided in the report issued by the forensic doctor reveals that, if the current haemorrhage rate suffered by the unidentified patient were to continue, and in view of the levels of haemoglobin that appear in the request, leaving the patient untreated would pose a serious threat to her life. Thus, and as stated by [ La Paz hospital ], since refraining from any medical treatment for the patient coming from Soria (whose identity is unknown) could lead to a fatal outcome, and there is no reliable evidence of any refusal by the patient to receive medical treatment, in order to safeguard the supreme legal value that is the right to life, authorisation must be given to treat this patient with the medical and surgical measures necessary to safeguard her life and physical integrity.” The operative provision granted authorisation “to treat the patient arriving from Soria, whose identity is unknown for the moment, with the medical or surgical measures necessary to safeguard her life and physical integrity”. The decision indicated that it could be appealed against within five days of being notified. 29.     The steps described above were taken while the ambulance was on its way. The applicant was unaware of them. D.    Treatment of the applicant at La Paz hospital 30.     The parties disagreed over the exact time of the applicant’s arrival at La Paz. According to the applicant, it was at or shortly after 2.20 p.m., based on the time recorded on certain documents that were created by the hospital as part of the admission process. The Government put the time of arrival as around 2.50 p.m., based on the form recording her admission to the emergency department and a statement provided by the doctors who treated her there. The parties were also in disagreement over the seriousness of the applicant’s condition at that point in time and, related to that, the therapeutic alternatives. Their respective positions are included in the summary of their arguments below. 31 .     The applicant was conscious when she arrived. As noted in her medical file, she was assessed as being at the highest point of the Glasgow Coma Scale (a score of 15, indicating the patient is fully alert). The doctors there considered that there was an imminent risk to the applicant’s life due to the amount of bleeding and that she required immediate surgical intervention. Treating the situation as a medical emergency, the hospital staff did not go through the usual procedure for seeking informed consent to surgical procedures. For her part, the applicant did not produce any document setting out her refusal of blood transfusion, nor did she refer to her advance medical directive which, in any event, was not part of the physical file sent with her from Soria. The National Register of Advance Medical Directives, where her directive was also held, was not consulted. It was still the applicant’s understanding that she was to undergo uterine artery embolization, not having been informed of the nature of the intervention that was about to take place. 32.     The applicant was taken into the operating theatre at 3 p.m. She was given a general anaesthetic and surgery commenced, consisting of a hysterectomy and double salpingectomy. There was major bleeding during the operation, necessitating three transfusions of red blood cells. 33.     The applicant’s husband arrived at La Paz about an hour after his wife and was informed that she was undergoing surgery. 34.     The following day, 8 June 2018, the applicant was informed about the duty judge’s decision, and about the surgery and transfusions that had been carried out. The medical file states: “The patient is informed of the events that occurred during the operation, and risk to life due to a massive haemorrhage, with extreme anaemia, that occurred when she was under the effects of general anaesthetic. ... She expresses her disagreement with the transfusions administered.” 35 .     In a written statement made for the purposes of the proceedings before this Court, the applicant described the transfusions as “like a rape of my person, something disgusting, ... very, very bad”. E.     The ensuing proceedings 36.     The applicant sought a copy of the duty judge’s decision, which she received on 12 July 2018. She then applied to have it set aside ( recurso de reforma ) and also brought a subsidiary appeal against it ( recurso de apelación ). 37 .     In her submissions, the applicant impugned the reasoning of the duty judge’s decision, observing that it had been issued on the unilateral application of the hospital without consulting her, and that not even her identity had been communicated to the duty judge. She argued that there had been a distortion of the facts inasmuch as it had been taken that she was refusing all forms of treatment for her condition. There was only one specific treatment that she refused – blood transfusion. She had been prepared to accept any other type of treatment that La Paz could provide to her, this being exactly why she had been transferred there. She further complained that the decision had not been notified to her, denying her the legal protection of her rights (referring to Article 24.1 of the Spanish Constitution). She appended to her submissions copies of her advance medical directive, her continuing power of attorney and the informed consent document from the Soria hospital. These established that the duty judge had erred in referring to the absence of evidence of her refusal of certain treatments, she maintained. 38.     The applicant then invoked the rights set down in Articles 15 and 16 of the Constitution, as well as in Articles 8 and 9 of the Convention. She expressly cited the judgment of this Court in Jehovah’s Witnesses of Moscow and Others v. Russia , no. 302/02, 10 June 2010, and argued that neither the State nor the courts were permitted to interfere with the freedom of the individual to make choices in relation to their health. The contested decision therefore represented a violation of her rights under the abovementioned provisions of the Convention. 39 .     In her conclusion, the applicant asked that the decision be annulled, and further that it be amended so as to comply with her rights and notified to La   Paz hospital so that in future the rights of patients would be respected. 1.      Initial examination of the applicant’s appeal 40.     Observations on the applicant’s appeal were submitted by the local prosecutor (the same one who had been consulted by the duty judge before she ruled on the doctors’ request). The local prosecutor stated the view that the decision had been fully justified in light of the particular factual and legal considerations. She noted that the specific details of the treatment given to the applicant were unknown, with no evidence whether a blood transfusion had actually been given or not. She further noted that the informed consent document submitted by the applicant lacked her signature (on this issue, see paragraph 54 below). 41.     The application to set the decision aside was dismissed on 22 August 2018 by the same judge who had issued the contested decision. In the judge’s reasoning, the circumstances giving rise to the decision were recalled, i.e., the gravity of the applicant’s condition, as described by the doctors at La Paz and confirmed by the forensic doctor, her refusal of “any” medical treatment, and the danger this represented to her life. It was noted that the applicant had expressed her will orally but had not provided anything in writing. It further noted that it was not stated in the application what treatment the applicant had received. The judge referred to the applicant’s advance medical directive, which the latter had appended to her submissions, observing that it had been drawn up almost a year before the operation and that it was not clear whose signature appeared on it. She concluded that it was not known in any event whether the applicant had received any form of medical treatment that she expressed her refusal of. 42.     In the same decision, the judge declared her subsidiary appeal admissible, thereby accepting it for examination by the Audiencia Provincial . 2.      Proceedings before the Audiencia Provincial 43.     The applicant’s submissions before this court can be summarised as follows: She argued that in rejecting her application to set aside the contested decision, the judge had avoided the substantive issue in the case (i.e., violations of the Constitution, the Convention and Spanish law) on the incorrect basis that her refusal of blood transfusions had not been expressed in writing, which it had. Moreover, as provided in the relevant domestic law, where the patient is conscious and capable and clearly expresses their will, this must be respected. She referred to the informed consent document, which could not be disregarded since it was part of the medical file and was the very reason for the transfer to La Paz. As for her advance medical directive, had there been any doubt about it on the part of the judge or the La Paz doctors, they should have consulted the relevant Register (it being held in the Castile and Leon Register and also in the National Register –   see further under “Domestic law and practice” below). Taking account of these documents setting out her rejection of blood transfusion, and more particularly of her verbal statements to the doctors, there could not be any doubt about her clear, manifest and unequivocal will in this regard. To the remark made by both the local prosecutor and the judge about it not being known whether the applicant had actually received a blood transfusion, she responded that this was irrelevant because her challenge was to the decision that had been issued beforehand granting authorisation to the La Paz doctors to take such action as they considered necessary; what had in fact happened subsequently was, from this perspective, of lesser importance. Even had there not been a blood transfusion, the legal harm had already been done by the decision permitting treatment that was contrary to her will, her conscience and her religious beliefs. In any event, the fact that transfusions had been given was recorded in her medical file. She further contended that there were errors and contradictions in the reasoning dismissing her appeal, noted that she had not had access to the opinion of the forensic doctor, and that the latter had issued her opinion without examining the patient. She asked the court to declare the contested decision to be contrary to the law and substitute it with one that was compatible with current legislation and case ‑ law, and that this be notified to La Paz. 44.     The local prosecutor submitted that the appeal should be dismissed, and the decision confirmed. 45 .     The Audiencia Provincial gave its ruling on 15 October 2018, dismissing the appeal. It stated at the outset that the issue before it was limited to the question of the lawfulness of the contested decision. It then set out the relevant provisions of Act No. 41/2002, namely Article 2.4, Article 8.1-3 and Article   11.1 (see under “Domestic law and practice” below for the text of these provisions). It acknowledged the relevance of the other constitutional and legislative provisions referred to in the applicant’s appeal submissions. The court took it that the applicant had been able to freely express her will at the time of the surgery (“ la recurrente podía manifestar libremente su voluntad al tiempo de producirse la intervención ”), finding no indication to the contrary in the materials before it. It was therefore necessary to take account of what she had decided at that point in time. It referred to a clear tendency in case-law towards respecting the free, voluntary and conscious decision of a capable adult patient with respect to any form of medical intervention, such as a blood transfusion. This was exactly the stance taken in Act No. 41/2002. 46 .     The court observed that Act No. 41/2002 required that both the refusal of a specific treatment and consent to it must be stated in writing. The only document of relevance in the file was the informed consent document, which was key to the decision to be taken; oral refusal or consent in relation to blood transfusion was insufficient. As for the applicant’s advance medical directive, the court considered that it was not applicable because, as appeared from the file, at the time of the intervention she had been capable of freely deciding whether or not to submit to blood transfusion. 47.     The court noted that the informed consent document bore the signature of the doctor but not that of the patient. No explanation for this had been given. It considered that the lack of a signature prevented it from finding that the patient had either refused or accepted the