Malpractice is regulated by the Romanian Law no. 95/2006, republished recently on August 28, 2015. Under this law, malpractice is regulated in the chapter regarding the civil liability of medical staff and is defined as " a professional error committed in the practice of medicine or medical-pharmaceutical, tortious on the patient, involving the civil liability of medical personnel and medical, health and pharmaceuticals products and services provider".
The content of art. 653 sets out the limits in which the civil liability of medical staff can be invoked, adding that the medical staff (which includes the doctor, dentist, pharmacist, nurses and midwives who provide medical services) can be held liable for damages caused by error, which include negligence, imprudence or insufficient medical knowledge in the profession through individual acts in procedures for prevention, diagnosis or treatment.
Moreover, the medical personnel will be held liable for damages arising from breaches of regulations regarding confidentiality, informed consent and mandatory medical assistance as well as for damages to the profession and when they exceed the limits of its competence, except in cases of emergency when there is no competent available medical staff.
An important factor established by Law no. 95/2006 on healthcare reform is that the civil liability regulated by this law will not exclude the criminal liability if the act that caused the damage is at the same time a crime under the law.
Regarding the form of guilt, the law states that all persons involved in the medical act will respond in proportion to the degree of fault of each of them. However, there are situations where medical staff will not be held liable for damages and losses caused in the practice, namely when:
▪ they are due to working conditions, poor endowment with equipment for diagnosis and treatment, nosocomial infections, side effects, generally accepted complications and risks of investigation and treatment methods, hidden defects of sanitary materials, equipment and medical devices, used medical and sanitary substances;
▪ acting in good faith in emergencies, respecting the granted competence.
In terms of obtaining the consent, it is provided that in order to be subjected to methods of prevention, diagnosis and treatment that hold a potential risk to the patient, after having them explained to them by a doctor, dentist, nurse / midwife, the patient is asked for his/her agreement in writing. The legal age of expressing consent is 18 years, but there is a possibility for minors to express their consent in the absence of parents or legal representative under specific conditions. In fulfilling his/her obligations regarding obtaining consent, the medical staff must present the patient information at a reasonable scientific level for the patient’s power of understanding.
Moreover, the medical staff has an obligation to provide medical / health care to a person if they have accepted the person in advance as a patient, but the medical staff has the obligation to accept the patient in emergency situations, when the lack of care could endanger in serious and irreversible ways the health or life of the patient.
Medical staff that provide healthcare in the public and / or private sectors, in a location with special destination for healthcare or when it is granted outside of this place, must conclude a malpractice insurance for the professional liability cases, for the damages caused by medical act. This insurance is an essential condition for employment.
The harm insurer offers indemnities for the damages of which the medical staff in held responsible in accordance with the law, to third parties which are found to have been subjected to an act of medical malpractice, as well as for the judgement costs of the person injured by the medical act.
Holders or their representatives are obliged to notify in writing the insurer or, where appropriate, the insurers on the existence of an action for damages, within 3 working days of the date on which they are aware of this action.
Regarding the authority which holds a supervisory role regarding cases of malpractice, in the public health county departments and Bucharest is constituted the Monitoring and Professional Competence Commission for malpractice cases, which shall, by decision, establish whether a concerned situation was, in fact, a malpractice case.
The Commission may be notified by the person or, where appropriate, legal representative, who is considered a victim of an act of malpractice committed in the exercise of activities of prevention, diagnosis and treatment or by the successors of the deceased as a result of an act of malpractice attributable to an activity of prevention, diagnosis and treatment.
It is useful to know that acts of medical malpractice in the work of prevention, diagnosis and treatment are prescribed within 3 years after the injury, except for acts that are considered crimes by the Romanian law.
For more details regarding the law of malpractice in Romania or for competent legal representation with the authorities in such a case, please do not hesitate to contact one of the lawyers within the Darie, Manea & associates law firm who will guarantee its clients complete information.