Italian liability insurance contracts do not address covering the costs of trial associated damages occurring in the participating patients home country.
The Decree of the Ministry of Health of 14 July 2009 provides for a time limit only, not a territorial limit. The time limits set forth in the insurance may not be shorter than 24 months for the occurrence of damage and 36 months for the presentation of damages from the end date of the trial. The date of conclusion of the trial is defined as the last medical/surgical, diagnostic and/or therapeutic service performed according to the trial protocol for the last patient enrolled in Italy. In the case of trials with the potential to cause harm detectable at a longer distance, the period shall be extended.
There are no national health insurance rules or experiences in Italy concerning coverage of any additional costs for a patient living in Italy when participating in a trial in another country.
There are no national health insurance rules or experiences in Italy concerning coverage of follow-on healthcare costs occurring after a patient has returned from participating in a clinical trial in another country. In general terms, a patient who is an Italian citizen can benefit from the national health service when he/she is in Italy. If the patient is a foreign citizen legally present in Italy, he/she can register for the National Health Service.
No legal framework in Italy, however at regional level there are multiple local regulation which may enable the medical treatment of a patient coming from another country. Considering the provisions of Legislative Decree No. 211 of 24 June 2003 on informed consent, it can be argued that the foreign patient (or legal representative in the case of a minor or an unable patient) must be able to give informed consent, understanding the objectives, risks and inconveniences of the trial, the conditions under which it will be carried out, and must also have been informed of his right to withdraw from the trial at any time.
Guidelines for the collection of informed consent issued by AIFA in 2020 take into account foreign participants who may not understand certain scientific terms. The Guidelines in particular state that in the case of participants who do not adequately understand Italian language it may be necessary using translated material and/or cultural mediator for the translation.
For observational studies, AIFA (Italian Health Agency) provides an informed consent simplified compared to that for experimental studies, and, analogically, it must be understood by the patient (included the foreign one) in all its elements (Guideline for the Classification and Conduct of Observational Studies AIFA, 2024).
There are specific ethics committee requirements:
Ethics committees have to adopt a regulation detailing their activities and functions and among the several elements they have to assess, there are the criteria for inclusion and enrolment of patients set out in the study protocol, but we are not aware of any specific requirements for patients living in another country.
Paragraph 2.8.1 of the GCP E6(R3) provides that Prior to consenting and enrolling participants, the investigator should have the IRB/IECs documented approval/favourable opinion of the informed consent materials and process; therefore in case of a patients who does not speak the local language the approval should be on the Informed consent of the mother tongue and a translator presence.
The Decree of the Ministry of Health of 14 July 2009 does not provide any specific requirements for foreign patients, but we can argue that same rules would apply since the coverage is for patients enrolled in a study conducted in Italy, independently from the citizenship.
There are no specific national provisions on the coverage of costs incurred by patients other than those stated by European legislation. Only in the “GUIDELINES ON REGULATORY SIMPLIFICATION AND ELEMENTS OF DECENTRALISATION FOR THE CONDUCT OF CLINICAL TRIALS OF MEDICINALS IN ACCORDANCE WITH REGULATION (EU) No 536/2014” issued by AIFA (Linea Guida Semplificazione e studi decentralizzati_02.08.2024(1), it is provided the reimbursement of expenses related to accommodation, meals, transport, incurred by participants in clinical trials to travel to the trial site, without providing limits in the case of travel from other Countries.