An important aspect of the doctor-patient relationship is informed consent. The ECHR has established that patients have the right to adequate and full information about their medical treatment, risks and alternative treatments. Moreover, ECHR case law is convergent in the sense that States Parties are under an obligation to adopt regulatory measures to ensure respect for the physical integrity of patients and to protect them, as far as possible, from the serious consequences that medical interventions may entail. The imposition of treatment without the consent of the patient shall be considered as an infringement of the physical integrity of the person concerned.
Basically, the doctor has an obligation to inform patients of the foreseeable consequences that the planned medical intervention may have on the physical integrity of patients and to inform them accordingly. If such a foreseeable risk arises without the patient having been properly informed in advance by his doctor, then the doctor can be held jointly and severally liable with the healthcare provider. The Romanian legislator has made it incumbent on the doctor to obtain informed consent after explaining in advance, in the patient's understanding, the methods of treatment, diagnosis, prognosis, potential risks, etc. The patient must understand what is happening and be able to make fully informed decisions accordingly.
In a recent judgment (2023), the High Court of Cassation and Justice, which was seized with the resolution of an action in tort (appeal), held in the grounds of the judgment that the ethical-legal reflections on the relationship between the doctor and his patient have as a central element the obtaining of the patient's informed consent, as regulated by Law 95/2006 in Art. 660 et seq. The patient is entitled to know the diagnosis of his illness, the possibilities of intervention and treatment, the risks to which he is exposed, the chances of cure or the dangers of worsening his state of health, in order to be able to express his 'informed consent' freely and in full knowledge of the facts.
Civil liability for medical malpractice may be incurred, along with other professional errors committed in the performance of preventive, diagnostic and treatment activities, and for failure to comply with legal regulations on obtaining informed consent from the patient. Failure to inform the patient of certain medical matters which, if they had been known, would have given the patient the possibility of choosing a particular solution, is not only a breach of a professional duty giving rise to civil liability, but also an ethical fault by disregarding the patient's dignity as a human being.
The duty to inform the patient is a separate and autonomous duty from the duty of care, with legal consequences. Obtaining the patient's informed consent is an essential condition for granting treatment or performing surgery. Lack of information can lead to harm to the patient for the loss of the opportunity to avoid the harmful risk of choosing medical care, receiving a particular treatment or having an intervention that endangered his or her life or even resulted in the loss of life.
From a legal point of view, proof of compliance with the obligation to inform the patient is the responsibility of the doctor, dentist, nurse, midwife as the holder of this legal obligation which is, by its concrete content, an obligation of result and not of means, because the duty has a precise purpose, namely to provide the patient with data and information on his state of health, treatment or surgery.
In view of the jurisprudential perspective and the legal consequences of not obtaining informed consent or obtaining incomplete informed consent, it is necessary to pay particular attention to the way in which the patient's informed consent is obtained, in the sense that the standardised informed consent must be adapted on a case-by-case basis and not be a mere formality carried out prior to the medical act by unqualified staff.