The Italian version of this article has been first published on AgendaDigitale.eu.
In order to reduce the spread of COVID-19, on March 19 the Head of the Civil Protection Department adopted an ordinance (“Ocdpc 651/2020” or “Ordinance“) allowing a citizen to receive from his/her physician an electronic prescription number (numero di ricetta elettronica – “NRE“), which is necessary to get a prescription drug from a pharmacy, without going to the doctor’s office. This is intended to limit the movement of people and, consequently, the risk of contagion.
Therefore, the Ordinance clarifies that it is not necessary to receive a paper memorandum of the e-prescription from the physician and introduces alternative tools, all in an effort to foster the dematerialization process.
1. Ocdpc 651/2020: boost the use of e-prescriptions
The Ordinance provides each patient the opportunity to ask his/her physician to transmit the dematerialized memorandum or the NRE, instead of providing a paper memorandum of the e-prescription, which would require them to go to the physician’s office physically.
Virtual communication of the NRE
Specifically, the patient can obtain the dematerialized memorandum or the NRE from the physician in the following ways:
Moreover, a patient who has activated an Electronic Health Record (fascicolo sanitario elettronico – “FSE“) may consult the e-prescription included in the FSE itself.
Thanks to digital transmission of the NRE, the patient does not have to go to the physician’s office to pick up a paper memorandum and may collect the prescribed drug in the pharmacy by communicating the NRE and showing the healthcare card.
E-prescriptions: expanding application of e-prescriptions
Moreover, according to the Ordinance, Regions and the Autonomous Provinces of Trento and Bolzano may (i) use dematerialized prescriptions for drugs distributed in a manner different from the conventional regime with the National Health Service (NHS) and (ii) allow persons to obtain supply of medicines requiring periodic patient check-ups at pharmacies.
Therefore, some Regions introduced specific measures to this end. For instance, the Campania Region authorized use of a dematerialized prescription for drugs “distributed on behalf” (farmaci per conto, e.g., oral anticoagulants).
2. E-prescription: the regulatory framework
The e-prescription for drugs reimbursed by the NHS was introduced by a Decree of the Ministry of Economy and Finance of November 2, 2011.
However, the Ministerial Decree of November 2, 2011 required the prescribing physician to provide the patient with a paper memorandum of the e-prescription, thereby slowing down the dematerialization process for prescriptions.
Therefore, with Ocdpc 651/2020 important steps have been taken in the process of complete dematerialization of e-prescriptions, as it identifies digital means that work as an alternative to printing a memorandum for transmission of the NRE.
Provisions established by Civil Protection ordinances will remain in force until the end of the state of emergency declared by the Council of Ministers, i.e., July 31, 2020.
However, on March 25, 2020, the Ministry of Economy and Finance issued a new decree on “Extension of the dematerialization of prescriptions and therapeutic plans and alternative methods to the paper memorandum of the e-prescription”, amending the previous Ministerial Decree of November 2, 2011. Said Ministerial Decree of March 25, 2020 will apply once the state of epidemiological emergency due to COVID-19 has ended, while during the state of emergency the provisions of the Ordinance will remain in force.
3. Opinion of the Italian Data Protection Authority on how to deliver an electronic prescription
On March 19, 2020, the Italian Data Protection Authority (“Garante”) published an Opinion on how to deliver an e-prescription (“Opinion”) according to the draft of the Ministerial Decree of March 25, 2020.
Against this backdrop, the Garante stressed that the use of digital means is compatible with the regulation on processing health data and provided specific instructions for delivering the dematerialized memorandum to the data subject (the subject to whom the personal data being processed refers). These modalities could already be applied in the immediate future and remain in place until the end of the state of emergency. In this regard, the Garante has expressed its consent to any emergency provision issued by the government to use such means, provided that these are implemented as described in the Opinion.
Therefore, the transmission methods introduced by the Ordinance shall be implemented, taking into account the indications provided by the Garante, which focus on the use of SMS and e-mail services. In the first case, the SMS must only include the NRE and no other detailed information. In the second case, the memorandum must (i) be sent as an attachment and not as a text included in the body of the message (precaution explicitly provided in the Ordinance), (ii) be accessible by means of a credential delivered separately to the data subject, and (iii) be protected by encryption techniques.
As the Garante pointed out, the latter digital method is already used in other healthcare sectors (e.g., for clinical examination results) and all patients can freely access it, unlike the method of including the memorandum in the FSE, which is an option available only to part of the population as it is not yet implemented throughout the country.
In light of the above, it is clear that the Ordinance, adopted in response to the spread of COVID-19 and the need to limit the movement of people, actually increased the use of electronic prescriptions by introducing important innovations related to communication (no longer on paper) of the related memoranda.
As anticipated, the provisions established by the Ordinance will become ineffective at the end of the epidemiological emergency due to COVID-19, after which the Ministerial Decree of March 25, 2020 will apply.
The Ministerial Decree of March 25, 2020 adopted most of the innovations introduced by the Ordinance and also extended the scope of the e-prescriptions.
Indeed, the Ministerial Decree of March 25, 2020 extended the scope of use of the e-prescription, providing the dematerialization of prescriptions for (i) medicines with AIFA therapeutic plan, (ii) medicines distributed through methods other than the conventional regime with the NHS, and (iii) medicines with restrictive prescriptions.
Moreover, it confirmed the alternative means for the use of e-prescription memoranda provided by the Ordinance while adding other tools. Specifically, the physician can make a memorandum available through the following channels:
The modalities for the use of these channels shall be established by a decree of the Ministry of Economy and Finance, in agreement with the Ministry of Health, subject to the opinion of the Garante. A draft of such decree was already submitted to the Garante which expressed his opinion on April 2, 2020.
Although this draft decree is not available yet, on the basis of the Garante’s opinion, it results that it provides for the concrete modalities to allow the dematerialization of prescriptions for drugs not reimbursed by the NHS. In particular, for the purposes of the dematerialization, the draft decree would establish that the prescriptions are uniquely identified through a number of Electronic Repeatable Recipe (RRE), assigned by the Central Reception System (SAC) when the doctor drafts the prescription. The dematerialized memorandum of the prescription can be sent to the patient, with the same modalities established for the dematerialized memorandum of the prescriptions of drugs reimbursed by the NHS.