Respect for private life<\/strong><\/p>\nLack of appropriate regulatory framework to protect applicant\u2019s right to informed consent in respect of kidney removal during urgent surgical intervention: violation<\/p>\n
Facts \u2013 Following an operation in Lviv Regional Clinical Hospital (the hospital), it was established that the applicant had likely developed post-operative internal bleeding. Having given oral consent, she underwent urgent surgical intervention during which her left kidney, previously diagnosed as healthy, was removed (a nephrectomy was performed). The applicant was not informed of the kidney removal and it was not mentioned on the discharge certificate summarising her treatment history. She later found out through an anonymous phone call.<\/p>\n
Civil proceedings brought by the applicant resulted in an award of damages in relation to her complaint that the removal of her kidney was concealed from her but were unsuccessful insofar as she complained that the removal had been carried out without her knowledge or consent.<\/p>\n
Law \u2013<\/p>\n
Preliminary issue \u2013 The applicant died while the present proceedings were pending before the Court. Her daughter had standing to continue the proceedings in her stead.<\/p>\n
Article 8:<\/p>\n
The patients\u2019 right to informed consent to medical interventions was guaranteed by Section 43 of the Fundamentals of Health Protection Legislation (FHPL). That provision also exceptionally authorised medical interventions without such consent in urgent situations where there was a real risk to the patient\u2019s life. That had been the situation in the present case, where it had been established at domestic level that the applicant\u2019s kidney had been removed in urgent circumstances, as the only available means of halting a life-threatening internal bleeding.<\/p>\n
The particularity of the present case was that the applicant\u2019s consent to the intervention had been sought and given, albeit without any discussion as regards a possible kidney removal in order to halt the bleeding. The applicant had argued that the \u201crisk\u201d of the nephrectomy should have been discussed with her prior to the operation or, at least, that her relatives should have been consulted before her kidney was removed. It was not apparent, however, on the basis of the available material, whether the applicant\u2019s medical team should have reasonably foreseen a possibility that her kidney might need to be removed or whether there had been a genuine opportunity to consult her relatives during the operation, without jeopardising the primary interest in saving her life. Although those questions had been of significant importance in establishing the scope of her caregivers\u2019 duty to seek her informed consent, neither the civil courts nor the authorities had scrutinised the relevant matters in detail. Their analysis had been confined to a general finding that her kidney had been removed on life-saving grounds.<\/p>\n
The difficulty in addressing the applicant\u2019s relevant and important arguments had stemmed from the lack of necessary guidelines, regulations, professional standards, hospital records or other pertinent documents. It was not apparent that at the material time there existed, apart from the FHPL, any national regulatory instruments establishing any procedures to be followed for documenting patients\u2019 consent to surgical interventions, contacting their relatives in emergency settings, or detailing, in particular, the interrelation between the notion of \u201cconsent\u201d as stipulated in Section 43 of the FHPL and the \u201crisks\u201d to be discussed with the patients as required by Section 39 of that Act in the context of ensuring that the patients\u2019 \u201cconsent\u201d be informed. Likewise, the hospital did not have in place any formalised record-keeping practices or standardised procedures for informing the patients of the foreseeable risks of planned interventions or consulting their relatives and designating contact persons in the event of an emergency. The hospital\u2019s practice of taking their oral consent only, regardless of the type and seriousness of the interventions proposed, made it impossible to trace what information had been provided to a patient when seeking consent to a particular intervention. The hospital\u2019s chief doctor had not even been aware of the FHPL\u2019s existence. Further, the applicant\u2019s consulting physician at the hospital who had been part of the surgical team, had been a university faculty member. However, the two public institutions had omitted to issue a \u201cjoint order\u201d required by their partnership agreement as a pre-condition for admitting him to practice in the hospital, and had not developed any other instructions or instruments defining, in any detail, the scope of his personal responsibility when imparting information to the patients consulted by him at the hospital.<\/p>\n
States generally had a broad margin of appreciation as regards laying down their healthcare policy. Moreover, the Convention itself did not establish any particular form of consent. However, the setting up of some standard guidelines and formalised procedures, either at the national or the local institutional level, detailing key elements of the right to informed consent, guaranteed by the FHPL, such as \u201cthe risks\u201d to be discussed with patients and the scope of the practitioners\u2019 duty to contact their relatives or designated persons had been instrumental in discharging the respondent State\u2019s positive duty to set up an appropriate regulatory framework and ensure high professional standards in that area. In the applicant\u2019s case, such guidelines and procedures would have been equally necessary for guiding her medical practitioners in their day-to-day work, for enabling the supervisory authorities to intervene promptly in the event of any omissions, and for protecting both: the applicant from malpractice and her medical team from any possibly unfounded accusations.<\/p>\n
In view of the lack of any structured response by the State authorities to the applicant\u2019s allegations \u2013 which appeared to have been closely connected to the absence of any national or local guidelines, standards or formalised hospital records and procedures ensuring the proper implementation in practice of the general legislative provisions concerning the patients\u2019 right to informed consent \u2013 the Court considered that the respondent State had not fulfilled its positive duty to set up an appropriate regulatory framework to protect the applicant\u2019s right to informed consent.<\/p>\n
Conclusion: violation (unanimously).<\/p>\n
Lastly, the Court dismissed the applicant\u2019s complaint under Article 8 as to the State\u2019s alleged failure to protect her from concealment of information by her physicians for loss of victim status, accepting therefore the Government\u2019s preliminary objection in this respect. Her grievance had been sufficiently addressed by the domestic judicial system. In particular, a breach of her right to information concerning her health as guaranteed by the domestic law had been acknowledged and she had obtained reasonable compensatory redress.<\/p>\n
Article 41: EUR 4,500 to the applicant\u2019s daughter in respect of non-pecuniary damage.<\/p>\n