St Petersburg University scientists: half of the patients believe that informed consent to medical intervention is necessary to absolve the doctor of responsibility

The 13th Annual Scientific and Practical Conference with International Participation 'Medicine and Law in the 21st Century' has been held at St Petersburg University. More than a hundred experts – lawyers, doctors, scientists, and government representatives – discussed: how the burden on the healthcare system has increased during the pandemic; why lawyers face difficulties in qualifying crimes committed by doctors; and whether patients know why it is actually necessary to sign an informed consent at a doctor's appointment.

The conference was opened by Marina Lavrikova, Senior Vice-Rector for Academic Activities at St Petersburg University. She noted that the range of problems and legal issues related to the healthcare system is only expanding. The agenda includes issues of both legal and financial models of the Russian healthcare system, issues of insurance medicine, commercial activities, patients' rights, and medical errors. With the onset of the pandemic, the issues of social support for health workers and the handling of medical information, which has received a hitherto unprecedented level of distribution and interest from ordinary citizens, have become particularly acute.

The potential of the University in solving the conflicts that exist today is very significant.

Andrei Sarana, First Deputy Chairperson of the St Petersburg Health Committee 

During the pandemic, tensions in health care have risen. In 2020, the number of complaints to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) about the work of medical professionals increased by 37.3%. Obstetricians and gynaecologists top the list of complaints, followed by surgeons, dentists, oncologists, traumatologists, and therapists, said Aleksei Goriainov, Head of Rosmedconsulting's pre-trial and court dispute resolution practice. Among the reasons cited by experts for this trend are professional burnout, increasing workload, and the lack of a system for calculating the risks that a doctor may face in their work. The experts noted that not all doctors and not even all managers of medical institutions are aware of the consequences of careless or ill-considered actions not only when working with patients, but also when performing administrative or paperwork.

'The profession of a doctor has always been a high-risk one, associated with increased legal responsibility and special duties – observance of medical ethics and medical secrecy. Every year, the risks in a doctor's work are only increasing, and the mental stress is also growing,' said Igor Akulin, Professor of St Petersburg University.

According to experts, the position of health workers has worsened in the pandemic. This is because health workers of various levels and qualifications endure a test of their knowledge, skills, and experience on every shift, exposing their lives and health to an unprecedented level of risk. This, experts say, is confirmed by recent statistics of the World Health Organization: up to one and a half percent of all deaths from COVID-19 are among health workers.

However, with an increased workload, the possibility of error also increases. Participants pointed out that in the healthcare system, due to the complexity of prognoses and high risks, an acute one is the issue of establishing a causal link between defects in medical care and the adverse consequences for the patient, including determining the nature of the causal link. This also leads to problems in qualifying the actions of medical workers who have committed negligent crimes that have resulted in consequences. As the analysis of judicial and investigative practice shows, the correct legal assessment of the actions or, on the contrary, the inaction of doctors causes significant difficulties. The difficulties in the classification of official crimes committed by medical professionals stemmed to a large extent from their performance of both official and professional duties. Participants stressed that surveys conducted among medical professionals show that 90% of them are convinced that they need legal knowledge, including an understanding of the basics of criminal law. Appropriate training and risk assessment will enable them to improve their work.

The master's programme in Medical Law at St Petersburg University was launched 10 years ago and every year it becomes one of the most in-demand legal programmes. 111 master's students have graduated so far. They work in the largest medical centres and leading law firms in the country.

Another problem voiced during the conference is the discrepancy between the actual practical use of informed voluntary consent for medical intervention and its legal meaning and purpose. The Federal Law 'On the Fundamentals of Protection of Public Health in the Russian Federation' requires every patient to sign such a consent, suggesting that every person should be aware not only of the essence of medical manipulations, but also of their possible risks and adverse consequences. However, in practice obtaining consent is often reduced to a mere formality.

Sergei Belov, Dean of the Faculty of Law of St Petersburg University, spoke about a study in which St Petersburg University scholars analysed the attitude of doctors and patients towards the need to sign this document: 'Informed consent should be an expression of the patient's will, ensuring their right to control their own body, including awareness of the possible consequences of doctors' actions. The problem is that the consent in its current form is a standard document that does not take into account the specifics of the patient's health, the details of the upcoming treatment, and the possible risks.' In addition, according to Sergei Belov, consent almost always contains so much medical terminology and is written in such complicated language that most patients do not read it, and those who do cannot understand what it says. This reduces the legal effectiveness of consent to almost zero. 'It proves to be of little use, especially given that it is often asked to be signed at the registration desk when an outpatient card or contract is issued, even before a conversation with a doctor and a diagnosis is made.' The only exception is consent for surgery, but it is not always executed in accordance with the law – often already at the moment of premedication, when the patient is semi-conscious.

The legislator's introduction of the requirement to obtain patient consent is a legal reflection of a rejection of the paternalistic model of doctor-patient communication, in which the patient acts like a child, with no knowledge or ability to assess various risks and, consequently, unable to take responsibility for medical decisions. Unfortunately, it is very difficult to move away from such perceptions in Russian medicine.

How can responsibility for the risks to life and health be transferred to the patient when everything is decided for them, without explaining the nature of the medical manipulation and the risks associated with it? Informed consent does not help at all, even though it was invented for the sake of it.

Sergei Belov, Dean of the Faculty of Law of St Petersburg University

Researchers have found out that half of the patients and almost all doctors believe that a signed consent is needed only to protect the doctor and the medical institution and exclude liability of the organisation for possible negative consequences. 'The paradox is that the signed consent does not and cannot legally fulfil the role of limiting responsibility', noted Sergei Belov. To enable patients to make sometimes vital decisions about their health independently, the conference participants suggest increasing the amount of information provided to patients, reorienting medicine towards personalisation, and changing the system of planning the scope of medical care.