March 1, 2021

E-prescriptions now available also for drugs not reimbursed by the NHS

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]

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).

[1] For further information, please see COVID-19 emergency: increasingly dematerialized prescriptions.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
Search by...
Search
Follow us on
Follow us on