CEDH · CASELAW;JUDGMENTS;CHAMBER;ENG — 5 novembre 2024

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DENMARK (Application no. 25636/22)   JUDGMENT   Art 8 read in light of Art 9 • Private life • Medical treatment in the form of a blood transfusion administered to unconscious Jehovah’s witness, for his survival in an emergency situation, despite his advanced medical directive refusing such a measure • Interference clearly defined in domestic law and fulfilled accessibility and foreseeability requirements • No indication domestic law applied in an arbitrary or manifestly unreasonable way • Application of criteria set out in Pindo Mulla v.   Spain [GC] • Limited binding effect of “advance directive on medical treatment” under domestic law and requirements concerning refusal of blood transfusions within the State’s margin of appreciation • Legal requirement that blood transfusion be made on an informed basis in the context of the current course of illness, not met in the present case • Relevant and sufficient reasons • Interference “necessary in a democratic society” and proportionate to pursued legitimate aim of protection of health • Domestic authorities acted within margin of appreciation   Prepared by the Registry. Does not bind the Court.   STRASBOURG 5 November 2024   FINAL   17/03/2025   This judgment has become final under Article 44 § 2 of the Convention. It may be subject to editorial revision. In the case of Lindholm and the Estate after Leif Lindholm v.   Denmark, The European Court of Human Rights (Fourth Section), sitting as a Chamber composed of:   Gabriele Kucsko-Stadlmayer , President ,   Tim Eicke,   Armen Harutyunyan,   Ana Maria Guerra Martins,   Anne Louise Bormann,   Sebastian Răduleţu,   Mateja Đurović , judges , and Andrea Tamietti, Section Registrar, Having regard to: the application (no.   25636/22) against the Kingdom of Denmark lodged with the Court under Article 34 of the Convention for the Protection of Human Rights and Fundamental Freedoms (“the Convention”) by a Danish national, Ms Lilian Elisabeth Lindholm (the first applicant), and the estate of her deceased husband, Mr Leif Ingolf Lindholm (the second applicant, henceforth L), also a Danish national, on 18 May 2022; the decision to give notice to the Danish Government (“the Government”) of the application; the parties’ observations; Having deliberated in private on 15 October 2024, Delivers the following judgment, which was adopted on that date: INTRODUCTION 1.     This case concerns a member of the religious community of the Jehovah’s Witnesses, who was admitted to hospital as an emergency patient and was given a blood transfusion, despite having previously stated his refusal of this procedure, a principle which was part of his religious beliefs. The applicants complained under Articles 8, 9 and 14 of the Convention. THE FACTS 2.     The first applicant was born in 1953 and lives in Randers. Her late husband, L, was born in 1947 and died on 21 October 2014. 3.     The applicants were represented by Mr Shane Heath Brady, Mr   Petr   Muzny, and Mr Tyge Trier, lawyers practising in respectively London, Switzerland and Copenhagen. 4.     The Government were represented by their Agent, Ms   Vibeke Pasternak Jørgensen, of the Ministry of Foreign Affairs, and their co ‑ Agent, Ms Nina Holst ‑ Christensen, of the Ministry of Justice. 5.     The facts of the case may be summarised as follows. I.         The hospitalisation 6.     L had been a Jehovah’s Witness since he was fifteen years old. In 1970 he married his wife, the first applicant, who was also a Jehovah’s Witness. They had five children. 7 .     On 19 September 2014, in the afternoon, L, aged 67, was admitted to the emergency unit of a local hospital ( Odense Universitetshospital, medicinsk afdeling Ærø) having fallen about two metres through a roof. The medical records showed that he was admitted at 3.28 p.m. and was then conscious. The first applicant estimated that L might have been lying unconscious for up to an hour before he was found. He was transported by helicopter from the local hospital to the main hospital, it was noted in the medical records at 10.22 p.m. that on his arrival at the hospital L had been awake and could give his name but that he was disoriented and had no recollection of the fall. All information came from the first applicant. A CT scan was carried out and showed a small subarachnoid haemorrhage (bleeding between the membranes that surround the brain) and bleeding on the left side of the thorax (chest) and on the left side of the gluteal muscles (buttock muscles). 8.     Prior to his hospital admission, L had been taking blood thinners in the form of warfarin (Marevan 2.5mg) on prescription to reduce the risk of cerebral thrombosis from atrial fibrillation. One of the known side effects of warfarin is that it generally increases a patient’s tendency to bleed. Any bumps, blows or jolts to the body will therefore have a risk of increased bleeding. 9.     During the night of 19 - 20 September 2014, L began to have difficulty breathing. A new CT scan revealed that a massive accumulation of blood had developed by his left lung. A drain was inserted into the lung late in the morning of 20 September 2014. L’s medical records show that his condition at that time did not indicate a need for a blood transfusion. 10.     An entry in L’s medical records on 20 September 2014 at 9.05 a.m. stated that L was able to give his name and date of birth and that he understood that he was in hospital, but that he otherwise seemed disoriented. 11 .     According to entries in the medical records made on 20 September 2014 at 2.08 p.m. and 2.38 p.m., L’s daughter had informed the healthcare staff that L, as a Jehovah’s Witness, did not wish to receive a blood transfusion. In the afternoon of the same day, the healthcare staff were presented with an advance medical directive and a Health Care Power of Attorney ( forhåndsdirektiv og fuldmagt angående lægebehandling ), which were entered into L’s medical records. L had been carrying the document on his person when the accident happened. The advance medical directive had been signed by L on 11   February 2012 and stated as follows (emphasis in the original): “I, L ... am one of Jehovah’s Witnesses, and I direct that NO TRANSFUSIONS of whole blood, red cells, white cells, platelets, or plasma be given me under any circumstances, even if healthcare providers believe that they are necessary to preserve my life. I refuse to pre-donate and store my blood for later infusion.” 12.     According to the medical records, a doctor was called at 4.33 p.m. because L had lost consciousness. L was transferred to the hospital’s neurosurgical intensive care unit and a new CT scan was carried out. 13 .     At 6.15 p.m. a note was added that L’s haemoglobin level (blood cell count) had dropped from 10.0 to 6.1. and that “[t]he patient may not be given blood products because of his religious beliefs”. 14.     A further note at 7.40 p.m. recorded that “the patient is still not fully conscious”. 15 .     From the medical records of 20 September 2014 at 11.42 p.m. it appeared that the unit’s healthcare staff had had a conversation with L’s family (the first applicant and some of the children). The family repeated that L was a Jehovah’s Witness and did not wish to receive any transfusions of blood or blood components. The healthcare staff informed them that L was being treated in accordance with their wishes, but that he was in a very serious condition because of the atrial fibrillation, the blood accumulation near his lungs, and the added strain on his circulation. The family understood the gravity of his condition. 16 .     In the afternoon of 21 September 2014, L was transferred to the intensive care unit because the condition of his lungs was very poor. An entry in L’s medical records at 5.45 p.m. said that he was deeply unconscious by then and connected to a ventilator. By that point, L’s haemoglobin level had dropped to 4.2, but the assessment was that the “patient has no acute transfusion needs”.   The medical records further stated that it had not been possible to obtain L’s own position on receiving a blood transfusion in the current potentially life-threatening situation and that L had probably not changed his opinion since 2012, when he had signed the advance medical directive (see paragraph 11 above), but that the healthcare staff had been unable to verify that assumption. 17 .     In the evening of 21 September 2014, the healthcare staff had a conversation with the L’s wife (the first applicant), their daughter, and a support person, about the “problematic legal situation”. The family referred to the advance medical directive and requested that it be respected. They also referred to the fact that in 2010 L had been admitted to hospital because of serious gastrointestinal bleeding in his duodenum and that during that hospitalisation he had been conscious and had decided to refuse a blood transfusion, against the doctors’ recommendations. The doctor emphasised that following the incident on 19 September 2014 (see paragraph 7 above) L   had lacked the capacity to confirm his decision to refuse blood products and that the situation was potentially life-threatening. The doctor explained that the situation might escalate quickly so that the need for a transfusion might arise, and that the healthcare staff had a duty to treat L if they had had no confirmation directly from him about his decision to refuse blood products. At that time, L was still not in current need of a blood transfusion. The healthcare staff informed the family that the treatment with Konakion (vitamin K) and tranexamic acid (a synthetic amino acid used to treat and prevent blood loss) would be continued, and that treatment with erythropoietin (EPO) would be initiated. 18 .     During the night between 21 and 22 September 2014, a pressure gauge was inserted into L’s brain to monitor the pressure in his brain in case it became elevated as a consequence of the subarachnoid haemorrhage (intracranial pressure monitoring). Around noon on 22 September 2014, L’s haemoglobin level was at 3.7, the pressure in his brain had built up, and he had a suspected swelling of the brain tissue (oedema). An immediate CT scan was ordered. The healthcare staff were concerned that the decreasing haemoglobin level might cause an oxygen deficiency in the brain and an increased risk of bleeding. 19.     On 22 September 2014, the chief physician, X, consulted the medical health officer ( ombudslægen ) regarding L’s immediate need for treatment. His decreasing haemoglobin level, the swelling in his brain and the subarachnoid haemorrhage made it necessary to increase his haemoglobin to a level between 4.3 and 4.5. L was unconscious and unable to give consent. In an e-mail send at 12.19 p.m., the medical health officer gave the following reply: “... Advice given: The chief physician, X, was reminded ( guidet) of sections 19 and 24 of the Health Act ( sundhedsloven ) [a]s the patient is not competent and has not expressed his wishes in the current situation (but did so in 2012 in another context), there may be a need to give blood according to section 19 (if, however, there may be any possible way to avoid giving him blood, this should be sought in the light of the hospital’s knowledge of the patient). For the sake of the patient, his relatives and the staff (including a potential subsequent complaint), it is important that record keeping is done with great care and conscientiousness.” 20 .     According to the medical records of 22 September 2014 at 2.20 p.m., L’s haemoglobin level had dropped to 3.4, and increasing intracranial pressure (elevated pressure in the brain) had been observed. 21 .     The healthcare staff discussed the situation with L’s family again and explained the risk of suboptimal brain perfusion (marginally reduced oxygenation and a reduction in the supply of blood to the brain) and an increased risk of bleeding in the brain. The family maintained that L did not wish to receive a blood transfusion. 22 .     On 22 September 2014 at 3.28 p.m., the chief physician X decided to increase the haemoglobin level to between 4.3 and 4.5 by administering a blood transfusion. L was given one bag of blood which was prescribed on 22   September 2014 at 4.44 p.m. His haemoglobin level rose to 4.5. 23.     Seven days later, L showed no signs of returning to consciousness, for which there was no neurosurgical explanation. 24.     On 9 October 2014, L was transferred to the intensive care unit at another hospital ( Svendborg Hospital ). 25.     On 20 October 2014, the healthcare staff had a conversation with L’s wife and daughter about L’s condition and explained that permanent damage seemed unavoidable. In consultation with the family, active treatment was discontinued later that day, after which L received only palliative care. 26.     L died on 21 October 2014. It is not in dispute that the cause of death was not linked to the blood transfusion administered on 22 September 2014 (see paragraph 22 above). II.       The ensuing legal proceedings 27.     On 7 December 2014, the first applicant filed a complaint with the Patient Ombudsman ( Patientombuddet ) claiming that the blood transfusion had been administered against L’s will. 28.     On 8 October 2015, the Patient Ombudsman became part of the newly established Patient Safety Authority ( Styrelsen for Patientsikkerhed ), which was established to examine complaints against treatment facilities and healthcare professionals. 29.     On 17 December 2015, the Patient Safety Authority found no basis for criticising Odense University Hospital and concluded that the treatment provided to L had met the generally accepted professional standards and had complied with the Health Act. 30.     On 16 December 2016, the applicants, instituted proceedings in the Svendborg District Court ( Retten i Svendborg ) against the Patient Safety Authority (now the Patient Complaints Agency) relying on, inter alia, Articles 3, 8 and 9 of the Convention, alone and read in conjunction with Article 14 of the Convention. 31.     On 10 August 2018, the District Court referred the case to the High Court of Eastern Denmark ( Østre Landsret ) (henceforth “the High Court”). 32 .     By a judgment of 7 December 2020, the High Court found partly for the applicants. The majority (two out of three judges) found, on the one hand, that previous information, such as an advance medical directive, could not be conclusive when doctors had to decide whether a blood transfusion was required under section 19 of the Health Act (see paragraph 39 below). On the other hand, making an unconditional, formal requirement of informed refusal “in the current course of illness” a condition for not administering a blood   transfusion would mean that a person who was hospitalised in an unconscious state could not object to the treatment, no matter how unambiguous and well-documented their previous refusal of blood might be. Moreover, in the present case, the doctors had had no doubt about L’s absolute refusal of blood transfusion. Accordingly, there had been a violation of Articles 8 and 9 of the Convention. The wording of the reasoning was as follows: “All the essential evidence in the case – in particular L’s advance directive of 11   February   2012, his refusal of a possible blood transfusion during his hospitalisation in 2010, the available medical records, the statements given by [the first applicant and her daughter] and the statement by chief physician X – points unequivocally to the fact that L’s refusal to receive blood was a personal, religious decision. In particular, it is noted that at no time during the hospitalisation or afterwards has there been any doubt at all that the advance directive was completed and signed by L of his own free will on 11 February 2012, and that he was at that time capable of acting rationally. It must also be stressed that L decided to renew his advance directive after his hospitalisation in 2010. This is information which was essentially available when chief physician X decided that a blood transfusion should be carried out. He has explained, among other things, that he “at no time [doubted] the family’s statements about the patient’s wishes, but he had to do the right thing and follow the medical rules.” There was therefore no doubt about L’s decision, apart from the – in the light of the other evidence – theoretical doubt connected with the fact that L was unconscious when it first appeared advisable to carry out a blood transfusion, and that the doctors were therefore unable at that time to follow the procedure laid down in section 24, subsection   2 of the Health Act. Moreover, L was not found to have had an opportunity to make it known at the time of his admission, when he was still conscious, that he did not want blood. We note here that he was at that point dazed [ omtåget ] and suffering from amnesia, that it does not appear that he was questioned by the health professionals, and that he was carrying the advance directive on his person, which in itself indicates that he stood by his decision to refuse blood. After an overall assessment of the information available, we therefore find that at the time of the decision to give blood to L there was no reasonably justified doubt that he did not wish to receive blood even in the current situation of illness. There is no evidence of such special circumstances that chief physician ... otherwise had grounds for disregarding the wish. In these circumstances, we consider that it has been established that the decision to allow blood transfusion on 22 September 2014 was not necessary for reasons of critical social need, see Article 8, paragraph 2, and Article 9, paragraph 2, of the European Convention on Human Rights.” 33 .     On appeal, in a judgment of 1 February 2022 a seven-judge panel of the Supreme Court ( Højesteret ) unanimously found against the applicants for the following reasons: “Background to the Case and the Issues Following a fall, L was admitted to Odense University Hospital for emergency care on 19 September 2014. During his stay in hospital, he received a blood transfusion on 22 September 2014, while he was unconscious. The health personnel were aware of his declaration inter alia in his “Advance Medical Directive and Health Care Power of Attorney " of 2012, stating that, as a member of the religious community the Jehovah’s Witnesses, he did not want to be given blood under any circumstances, even if it was necessary in order to preserve his life. On 21 October 2014 he passed away without having regained consciousness. The cause of death was unrelated to the blood transfusion. On 17 December 2015, the Patient Safety Authority (now The Agency for Patient Complaints) decided that there were no grounds for criticising Odense University Hospital for giving L the blood transfusion. The main issue in the case is whether the Patient Safety Authority’s decision should be set aside ( tilsidesættes som ugyldig ) because the blood transfusion given on 22   September 2014 was administered in breach of the Health Act, in particular sections   19 and 24, or in violation of Articles 8, 9, and 14 of the Convention. The Health Act Under section 15 of the Health Act, no treatment may be initiated or continued without the patient’s informed consent, unless otherwise prescribed by law or provisions laid down pursuant to law or by sections 17-19 of the Act. The exception in section 19 includes, inter alia, cases where a patient who is temporarily incapable of giving informed consent is in a situation where immediate treatment is required for the patient’s survival. Chapter 6 (sections 22-27) of the Health Act contain rules about patient autonomy in special cases, including section 24, which deals with the right to refuse blood transfusions. Section 24, subsection 1, establishes that treatment involving a blood transfusion or blood products may not be initiated or continued without the patient’s informed consent. According to section 24, subsection 2, a patient’s refusal to receive blood or blood products must be given within the context of the current course of illness and must be based on information from the healthcare professional about the health consequences of blood or blood products not being administered during the treatment. Section 22 of the Act establishes that section 19 does not apply to inter alia section   24. This means that administering treatment without consent in, inter alia , situations where it is required for an unconscious patient’s survival under the ordinary rule in section 19 does not apply if the patient has refused blood transfusions in the context of the current course of illness. In such a situation, the patient’s refusal must therefore be respected, even if a blood transfusion is vital. If a person’s refusal to receive blood is stated before the current illness, it follows from section 20 of the Health Act and the preparatory notes to the Act ( Folketingstidende 1997-98, 2nd Compilation, Appendix A, Bill no. L 15. p. 533), that such an advance directive shall be treated as relevant and taken into account in the health staff’s treatment decisions if the directive can still be assumed to be current and relevant. However, according to section 24 compared with section 19 of the Health Act, an advance directive does not prevent doctors from administering a blood transfusion without consent, inter alia in situations where an unconscious patient has not made an informed refusal of blood transfusion in the context of the current course of illness and is in a condition where a blood transfusion is required for the patient’s survival. Hereafter, the Supreme Court finds that there was a legal basis in the Health Act for the blood transfusion given to L when he was unconscious on 22 September 2014, regardless of his advance directives that he refused blood. Emphasis is placed here on the circumstances that it is undisputed that following the accident he was unable to state his own wishes. The fact that during his fall and admission to hospital he carried his Advance Medical Directive refusing blood on his person does not meet the requirement in section 24, subsection 2 of the Health Act that a refusal of blood transfusions must be given on an informed basis and in the context of the current course of illness . Furthermore, according to the medical information in the case, it definitely appears that at the time when the blood transfusion was administered, he was in a condition where blood transfusion was required for his survival. The European Convention on Human Rights The court will deal secondly with whether the blood transfusion was a violation of the Convention on Human Rights. Under Article 8, paragraph 1, of the Convention on Human Rights, everyone has the right to private life, and according to paragraph 2 there can be interference with this right only where it is necessary for the protection of the health or of the rights of others etc. Article 9, paragraph 1 establishes that everyone has the right to freedom of religion and to manifest his religion, and under Article 9, paragraph 2 this freedom can only be subject to such limitations as are prescribed by law and are necessary in a democratic society in the interests of for example health or for the protection of the rights and freedom of others. Article 14 of the Convention contains a prohibition on discrimination on the grounds of, inter alia, religion. In its judgment of 10 June 2019 in case 302/02 ( Jehovah ‘s Witnesses of Moscow and Others v. Russia ), the Court found that the Russian authorities had violated the Convention on Human Rights by dissolving the association the Jehovah’s Witnesses of Moscow and banning the association’s activities, inter alia , with reference to the association’s encouragement of its members to refuse certain forms of medical   treatment, such as blood transfusions. The judgment states that refusing potentially life-saving medical treatment on religious grounds is a problem of considerable legal complexity, involving a conflict between, on the one hand, the State’s interest in protecting the lives and health of its citizens and, on the other, the individual’s right to personal autonomy in the sphere of physical integrity and religious beliefs, cf. paragraph 134. Furthermore, it is stated that the genuineness of a patient’s refusal of medical treatment constitutes “a legitimate concern”, given that health and possibly life itself are at stake in such situations, see paragraph 138. The Supreme Court thirdly finds that the judgment does not provide a basis for holding that the national legislature is precluded from establishing, as part of a combined balancing of different considerations, further conditions under which directives from members of Jehovah’s Witnesses refusing blood transfusions would be binding on health personnel. The requirement in section 24, subsection 2 of the Health Act that a refusal of blood transfusions must be given in the context of a current course of illness in order to be binding on health staff is further supported in a reply from the Minister of Health at the time, during Parliament’s consideration of the bill about the corresponding rule in section 15 of the previous Patients’ Legal Status Act (the Minister of Health’s reply to question number 4 of 2 April 1998 from the Parliament’s Health Committee, Bill no.   L   15 annex 25). It is stated in the reply that an advance medical directive setting out that the patient – who by then is unconscious or otherwise incapable – refuses treatment that involves blood transfusion is not binding on the physician, but shall obviously be taken seriously and be included in the considerations to be taken into account when deciding on treatment. In that connection, it is mentioned that both the Council of Europe’s Convention on Human Rights and Biomedicine and a number of other declarations only make it obligatory to take advance directives into consideration, and do not require that they are binding on treating staff. It is then stated in the reply that whether the issue is a refusal of blood transfusions or directions about psychiatric treatment or other medical intervention, introducing rules that advance directives shall be binding on treating personnel, including in situations where the patient’s situation is not hopeless, would give rise to serious concerns about patient safety and would involve immeasurable problems with the documentation needed in order to reasonably determine that those were indeed the patient’s settled wishes. Furthermore, the Minister said in his reply that it could not be ruled out that in the current situation the patient, had he or she been conscious, would have preferred to go on living. The present position is that an advance directive refusing blood transfusions or other medical treatment has a persuasive influence but is not binding if it is a matter of life-saving treatment of for example an unconscious patient. The requirement in section 24, subsection 2 of the Health Act that a refusal of a blood transfusion must be made in the context of the current course of illness in order to be binding on health staff is, as described, there to enable the balancing of personal autonomy, patient safety, and the documentation of a patient’s settled wishes. The legislature has found it proper to have a regulation that can prevent the risk that for example an unconscious patient dies because of insufficient vital treatment which, in the context of the current course of illness, he or she would have consented to. During the first days after L’s admission to hospital, he was treated with, inter alia, blood-forming medication in order to take into account his previous directives about not wanting a blood transfusion. It was not until it was thought to be required for his survival that a blood transfusion was given. Against that background, the Supreme Court finds that there are no grounds for determining that the blood transfusion that was given to L on the basis of the provisions of section 24 of the Health Act in conjunction with section 19 was a violation of Articles 8 or 9 of the Convention on Human Rights. As stated, section 19 of the Health Act allows life-saving treatment to be administered to an unconscious patient regardless of any advance directive from him or her about not wanting to be treated. The rule is general and is not restricted to blood transfusions. Therefore, the blood transfusion that was given to L was not a violation of Article 14 of the Convention on Human Rights, read in conjunction with Articles 8 and 9. Conclusion and legal costs ....” RELEVANT LEGAL FRAMEWORK AND PRACTICE I.         Domestic law and practice 34 .     The Patients’ Rights Act ( Lov om patienters retsstilling, no. 498 of 1   July 1998) was replaced by the Health Act ( Sundhedsloven, no. 546 of 24   June 2005 , which entered into force on 1   January 2007). 35 .     At the time of the events in the present case, the relevant law was section 15 of the Health Act, which read as follows: Section 15 “(1) No treatment may be initiated or continued without a patient’s informed consent, unless otherwise provided by law or by provisions laid down in pursuance of the law or by sections 17 to 19. (2)   A patient may, at any time, withdraw his or her consent given under subsection (1). (3)   For the purpose of this act, informed consent means consent given on the basis of adequate information provided by a healthcare professional: see section 16. (4)   Informed consent ... may be written, oral or, in certain circumstances, implied. ...” 36.     The corresponding preparatory notes to the former section 6 of the Patients’ Rights Act read as follows: “ The provision includes the basic rule about informed consent. No examination, treatment or care may be initiated or continued without the patient’s informed consent. This does not apply to cases where the patient is under 15 years of age or incapable of giving consent as described in sections 8 to 10 of the Act [now sections 17 to 19 of the Health Act], nor does it apply to exceptional cases where special legislation provides for compulsory treatment. Under subsection (2), a patient may withdraw his or her consent to treatment at any time. The subsection emphasises that consent must be freely given and that the patient can withdraw that consent at any time and decline any further treatment. That may be important in cases where, because of religious or other beliefs, a patient does not wish to receive certain types of treatment, such as a blood transfusion. Refusal to receive blood or blood products is a practice of the members of the religious community of Jehovah’s Witnesses. If a patient refuses any examination or treatment offered, an entry to that effect must be made in the patient’s medical records. ... The right to personal autonomy applies to the greatest extent possible, that is, in all cases where a patient is able to understand and assess his or her specific medical situation. ... The provision in subsection (3) defines the concept of ‘informed consent’, which is well-established within healthcare throughout the developed world and is used, inter alia , in international conventions. It is therefore considered appropriate to use this concept in the Act. The advantage of using this concept is that it combines in one concept two elements that are key to patients’ rights, namely information and consent, and makes it clear that consent depends on having full information about the state of health, treatment options, etc. Consent based on an insufficient level of information is inadequate when dealing with a matter as intrusive as medical treatment. If a patient has declined information under section 7(2) [now section 16 (2) of the Health Act], informed consent will still be considered to have been given, even if the amount and level of information may have been limited at the request of the patient. The information that must form the basis for voluntary and effective consent must contain the appropriate information on the nature of the medical condition, treatment options, risks and side effects, etc., to enable the patient to decide on the matter of treatment. In the provision, this is expressed by the wording that information must be adequate. The information must also be based on currently accepted professional standards in the field. The provision of information from a healthcare professional to a patient must be tailored to the individual patient so that, to the greatest extent possible, he or she understands the situation, etc. The key is to provide the patient with a basis for giving consent freely, that is, consent without any pressure. It is important that the healthcare professional ensures that informed consent is obtained at a point in the course of examination and treatment when the patient is best equipped to take a considered position on treatment and that the physical setting – the environment – will allow the patient to consider and decide on the issue of treatment. Where a patient is, inter alia , in a state of confusion because of medication or for other reasons, consideration should be given to whether it is possible to postpone giving the information and treatment until the patient is better able to take a considered position on treatment. However, informed consent should always be obtained well in advance of invasive treatment. ... Subsection (4) covers the form of consent, which may be written, oral or, in certain circumstances, implied. ... Consequently, the general rule in health law is that oral consent is sufficient for healthcare professionals to initiate or continue treatment, etc. ...” 37.     At the relevant time, the wording of section 16 of the Health Act read as follows: Section 16 “(1) A patient has the right to be informed about his or her state of health and treatment options, including about the risk of complications and side effects. (2) A patient has the right to decline any information under subsection (1). (3) The information must be provided on an ongoing basis and offer a comprehensible explanation of the condition, examination and planned treatment. The information must be provided in a considerate manner and be adapted to the individual circumstances of the recipient in terms of age, maturity, experience, etc. ...” 38.     The corresponding preparatory notes to the former section 7 of the Patients’ Rights Act read as follows: “This provision governs patients’ right to receive information on their state of health, treatment options, etc. ... Under subsection (1), every patient has the right to be fully informed about his or her state of health and about treatment options. The concepts of state of the patient’s health and treatment options are to be understood as including all information of relevance to the patient on health, diseases, methods of examination, prevention and treatment options, prognoses for the patient’s condition, risks, side effects, complications, care options, etc. The risk of complications or side effects is included specifically in the wording of the Act as it is often a very important factor for patients when considering a treatment option. ... The provision in subsection (3) describes how healthcare professionals must provide information under subsection (1). The information must be provided on an ongoing basis as needed and in clear and comprehensible language so that the patient is able to understand the situation, that is, his or her state of health, the treatment options available, the risks of complications and side effects involved in various interventions, etc. The information must be provided in a considerate manner and must be adapted to the individual circumstances of the recipient in terms of age, maturity, experience, etc. This includes a particular obligation for healthcare professionals to show consideration and care for patients who are not used to claiming their rights from authorities and healthcare professionals. ...” 39 .     At the relevant time, the wording of section 19 of the Health Act read as follows: Section 19 “If a patient who temporarily or permanently lacks the capacity to give informed consent, or who is under 15 years of age, is in a situation where immediate treatment is required for the patient’s survival or to improve the patient’s chances of survival in the long term or for a significantly better outcome of the treatment, a healthcare professional may initiate or continue treatment without obtaining consent from the patient or from the person with custody of the patient, the patient’s closest relative or the patient’s guardian.” 40.     The corresponding preparatory notes to former section 10 of the Patients’ Rights Act read as follows: “This provision allows the healthcare professional to provide treatment without consent where such treatment is urgent and typically life-saving. If a patient is in a situation where immediate treatment is required for the patient’s survival or to improve the patient’s chances of survival in the long term or for a significantly better outcome of the treatment, the healthcare professional may initiate or continue treatment without obtaining consent from the patient or a representative. The provision is based on the principle of necessity: the lesser good (the patient’s right to personal autonomy) must give way to achieve a greater good (preservation of the patient’s life and mobility). The main point of the provision lies in the immediate need for treatment. Such a need exists where ‘immediate treatment is required for the patient’s survival’, that is, immediate life-saving treatment, or where treatment is urgently needed to improve the patient’s chances of survival in the long term or for a significantly better outcome of the treatment. Where the patient is a fully conscious adult, informed consent must be obtained in compliance with the rules in sections 6 and 7 [now sections 15 to 16 of the Health Act]. Where the patient is a fully conscious person aged 15 to 17, informed consent must be obtained in compliance with the rule in section 8 [now section 17 of the Health Act]. In both cases, consent must be obtained in a manner appropriate to the urgency of the situation. ...” 41 .     At the relevant time, the wording of section 20 of the Health Act read as follows: Section 20 “A patient who is unable to give informed consent must be given full information and must be involved in discussing the treatment to the extent that the patient understands the treatment, unless this may harm the patient. The patient’s views must be taken into account, in so far as they are current and relevant.” 42 .     The corresponding preparatory notes to former section 11 of the Patients’ Rights Act read as follows ( Folketingstidende 1997-98, 2nd Compilation, Appendix A, Bill no. L 15. p. 533): “This provision applies in all cases where a patient does not have the capacity to give informed consent, that is, it applies to children and adolescents under 15 years of age, to immature children and adolescents aged 15 to 17 years (section 8(2)) and to patients who permanently lack the capacity to give informed consent (section 9). ... Patients who permanently lack the capacity to give informed consent constitute a very broad and heterogeneous group, covering wide variations of the inability to give consent. Often, a patient falling within this group will be able to understand some of the medical issues, in which case his or her views should be taken into account to the extent possible in the legal representative’s decision-making process. Reference is also made to the explanatory notes on section 9. The Council of Europe’s Convention on Human Rights and Biomedicine contains the following provision: ‘Article 9 – Previously expressed wishes Wishes relating to a medical intervention previously expressed by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account.’ Similar provisions can be found elsewhere - in, inter alia , A Declaration on the Promotion of Patients’ Rights in Europe issued by the World Health Organisation (WHO) in March 1994, and in the Finnish Legal Status Act (Act No. 785 of 17 August 1992). This general provision also applies to the relationship between patients and healthcare professionals under the Legal Rights of Patients Act. Where such previously expressed wishes are considered to be up to date and relevant, they must be given weight and must be taken into account by healthcare professionals when they take decisions on treatment.” 43.     At the relevant time, the wording of section 22 of the Health Act read as follows: Section 22 “Sections 15 to 16 on informed consent, section 17 on minors, section 20 on the involvement of patients and section 21 on the responsibility of healthcare professionals apply with the necessary modifications to the provisions of this chapter. However, section 17 on minors does not apply to section 26 on living wills.” 44.     The corresponding preparatory notes to former section 13 of the Patients’ Rights Act read as follows: “The provision in section 13 [now section 22 of the Health Act] entails that the fundamental rules on informed consent in sections 6 to 7 [now sections 15 to 16 of the Health Act] also apply to the special cases falling within chapter 3 [of the Act]. The rule on the independent decision-making capacity of minors in section 8 [now section 17 of the Health Act] also applies in respect of the issues of hunger strikes, refusals of blood transfusions and the treatment of terminally ill patients. ... The rule on immediate need for treatment, see section 10 [now section 19 of the Health Act], has also been left out of chapter 3 [of the Act]. A patient’s right of autonomy in special cases falling within chapter 3 [of the Act] must be respected even if, during the course of treatment, a situation arises where section 10 [now section 19 of the Health Act] could in principle apply, that is, a situation where the patient has become unconscious and his or her condition has become life-threatening. Accordingly, healthcare professionals are barred from carrying out treatment in such situation. Patient autonomy must be respected. ...” 45.     By Act no. 618 of 8 June 2016, and therefore after the incident giving rise to the present case, section 22 was amended by the addition of a sentence to the secti