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Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials in emergency situations

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the future (so-called advanced decision, sometimes also referred to as living will, and translated as “Biotestamento” in Italian ).

Advanced decision of medical treatments

Further to an inflamed political and social debate, sparked particularly by decisions of terminal patients (or the troubles faced by their family) to halt live-saving therapies, including artificial nutrition, the Italian legislature has now clearly stated the right of any person to refuse medical treatments or artificial nutrition, even if such decision may cause his or her death.

The law is intended to safeguard the right of the patients to decide on their life, and to protect from the risk of a criminal indictment those (physicians, close friends and family members) who for different reasons may be involved in the patient’s decision.

In that context, a deeply felt concern of patients suffering from life threatening diseases is that they could be unable to express their will on medical treatments at the moment in which a decision must be taken. To address such concerns, the law now provides for the right of any individual to state advance decisions on medical treatment in future (Disposizione Avanzata di Trattamento or DAT). Moreover, it is provided that the individual may appoint in the DAT a trusted person, who would be entitled to take decisions on medical treatments in case of incapacity of the concerned subject.

Clinical trials in emergency situations

A clinical trial may be of such a nature that it may be conducted exclusively in emergency situations (e.g. trials concerning medicinal products or medical devices whose therapeutic indication or medical use is concerned with conditions arising in those circumstances).

Clinical trials in emergency situations pose specific issues with regards to the collection of the informed consent, as the patient could be unable to provide his consent and, even when there would be sufficient time, under such exceptional circumstances there may be not an appointed legal representative who may take a decision.

Article 35 of Regulation (EU) No 536/2014 (Clinical Trial Regulation) specifically rules clinical trials in emergency situations, providing that informed consent to participate in a clinical trial may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the clinical trial. The regulation states that, among others, the following conditions must be fulfilled: (i) it should not be possible, within the therapeutic window, to supply all prior information to and obtain prior informed consent from the subject’s legally designated representative; (ii) the investigator should certify that he or she is not aware of any objections, previously expressed by the subject, to participate in the clinical trial. Although the Clinical Trial Regulation is not yet in force, similar issues may arise under the existing regulation.

Impact of DAT on clinical trials in emergency situations

There are no doubts that an opposition against the participation to a clinical trial in emergency situations clearly expressed by a subject in the DAT, or (as it may appear to be more likely) to the use of technologies similar to that to be tested, should impede the enrolment of the patient in the trial.

To that purpose, it is crucial that DATs are readily available to physicians. This seems to be possible only through the full implementation of the electronic patient file at a national level, where DATs may be uploaded upon patient’s request.