On December 30, 2020, the Ministry of Economy and Finance adopted a decree (“Ministerial Decree”) that provided the possibility for doctors to issue e-prescriptions for drugs not reimbursed by the National Health Service (“NHS”).
The Ministerial Decree is in line with the measures introduced during the COVID-19 emergency period in order to speed up the implementation of digital healthcare in Italy, including the Ministerial Decree of March 25, 2020 on dematerialized prescriptions for drugs reimbursed by the NHS.
1. Modalities for providing e-prescriptions for drugs not reimbursed by NHS
According to the Ministerial Decree, e-prescriptions for drugs not reimbursed by the NHS shall be drafted by doctors using a dedicated online platform (Sistema di accoglienza centrale – “SAC”). Patients may access the SAC to download their e-prescription or a memorandum of the e-prescription, that contains a number that identifies the electronic prescription (“NRBE”). At the patient’s request, the doctor may provide the patient with the memorandum for the e-prescription or the relevant NRBE via email or text message. E-prescriptions may also be placed in the patient’s electronic health records (Fascicolo Sanitario Elettronico – “FSE”), but only upon receipt of consent to their inclusion in the FSE from the patient.
Moreover, through the SAC patients may request the use of the e-prescription memorandum and select the pharmacy to submit the memorandum. Following the patient’s request, the SAC sends a notification to the pharmacy chosen by the patient. If the requested drugs are available and can be dispensed, the pharmacy accepts the patient’s request and then the SAC immediately notifies the patient, who can pick up the drugs from the pharmacy.
2. Use of e-prescription memorandum during the COVID-19 emergency period
The Ministerial Decree introduces some special options, intended to be available only during the COVID-19 emergency period. In brief, those are as follows:
- The option for doctors to provide the NRBE to the patient not only via email and text message but also by phone;
- The option for a patient to forward the NRBE or a dematerialized memorandum directly to a pharmacy (together with a tax identification code) using the same modalities; and
- The option for a pharmacy to deliver the drug directly to the patient’s home.
Again, the Ministerial Decree specifies that these options are intended to be available only during the emergency period but, considering the way home delivery services have proliferated in recent months, it will be interesting to see whether and how such services will be regulated in the future.
3. Next steps
The Ministerial Decree provides that the Ministry of Economy and Finance shall communicate data on services provided by pharmacies on the basis of e-prescriptions issued to the relevant local healthcare facilities, the Italian Medicines Agency (Agenzia Italiana del Farmaco – AIFA), the Ministry of Health, and the Regions.
To this end, the Ministerial Decree requires that the data be pseudonymized and references for that purpose a forthcoming regulatory provision establishing methods for communicating such data that will need to be approved by the Italian data protection authority.
The Ministerial Decree, which entered into force on January 30, does not indicate timing for the adoption of these provisions. Furthermore, in order for the system to be fully functional, some technical measures will need to be implemented, especially when it comes to ensuring integration between the national platform (SAC) and regional platforms (SAR) and between these platforms and the management systems of doctors and pharmacies. It will probably take some time for the system to be set up completely.
Nevertheless, the extension of dematerialization to prescriptions of drugs not reimbursed by the NHS gives another boost to the digitalization of the entire process, which starts with a televisit, leads to an e-prescription, and ends with delivery of the drug to the patient (either in the pharmacy or, potentially, at the patient’s home).
 For further information, please see COVID-19 emergency: increasingly dematerialized prescriptions.