Service pharmacy: The new resolution of the Lazio region broadens the horizons of telemedicine in pharmacy

On June19^th, 2025, the regional government of Lazio approved the Resolution n. 150/2025 (“Resolution”) for the activation of telemedicine services (specifically, services such as ECGs, cardiac Holter monitors and blood pressure Holter monitors) provided at the expense of the National Health Service (“NHS”) by local pharmacies participating in the project to all citizens of the region. The Resolution aims at bringing healthcare closer to citizens (especially in inland areas) and allows for a reduction in waiting lists and a positive return in terms of the quality of care provided by NHS.

This initiative is part of the trial activated by the Lazio Region for the provision of healthcare services by pharmacies at the expense of the NHS[1], within the framework of the so-called “Pharmacy of Services”[2]. The Resolution is now facing opposition by the Association of Independent Healthcare Companies (AISI) and several other operators in the sector (medical laboratories accredited with the NHS), which disagree with the possibility of carrying out diagnostic tests in pharmacies without appropriate requirements and effective medical supervision.

The Resolution of the Lazio Region

 The Resolution launched a trial for the provision of specific telemedicine services by pharmacies at the expense of the NHS. More specifically, the Resolution allows local pharmacies participating in the trail (“Affiliated pharmacies”) to provide the following telemedicine services at the expense of the NHS to all Lazio citizens: ECG, cardiac Holter monitoring, and blood pressure Holter monitoring. To this end, Affiliated pharmacies sign a supply contract with a provider that offers telereferral services and also the IT platform that allows data transmission between the device used and the reporting center and the release of the relevant test results.

Affiliated pharmacies must ensure the use of the technological devices and equipment necessary for the performance of the services. These devices must be equipped with relevant conformity certificates and the pharmacist in charge is responsible for correctly installing and maintaining the devices (according to the manufacturer’s instructions) as well as for any inaccuracy in the results due to deficiencies in the installation and maintenance of the infrastructure. As the tests are reimbursable by the NHS, they will be carried out in the pharmacy upon presentation of the relevant electronic or paper medical prescription. Pharmacies are responsible for choosing the provider and reporting center used.

• Requirements and conditions of participation

The tests must be carried out in compliance with current legislation on Pharmacy of Services in appropriate areas within the pharmacy premises that are suitable from a health and hygiene point of view, and in any case separate from the other areas of the pharmacy, to ensure the necessary patient confidentiality and the correct performance of the tests.

To meet these requirements, the services may also be performed outside pharmacy opening hours. Pharmacists who intend to perform these examinations are required to attend specific training courses. Finally, pharmacies participating in the trial project must display a notice informing users of the services offered.

To participate in the project, pharmacies must submit to the competent authority a specific form attached to the Resolution which aims at certifying compliance of the pharmacy with the above requirements as well as identifying the service that the pharmacies wish to provide. The authorities accept applications for membership (subject to verification of the requirements) in the order in which they are received until the targets are reached.

• Operating procedures

Patients who need to undergo ECG, cardiac Holter and blood pressure Holter will be informed by their doctors of the possibility of having them performed at Affiliated pharmacies. Patients (or a family member in the case of minors) who wish to have the tests carried out at a pharmacy should contact one of the Affiliated pharmacies to arrange the appointment. The service will be carried out by the pharmacies upon delivery of the prescription and once they have obtained the patient’s consent to the processing of personal data. Once the test is complete, pharmacists send the collected data electronically to the provider, who will then proceed with the reporting.

The telereferral services provided by pharmacies must have specific characteristics: (i) they must be certified by the relevant authorities and, once fully operational, they must be integrated with the National Telemedicine Platform; (ii) they must be carried out by doctors affiliated with the NHS, i.e. doctors working in NHS-accredited facilities or directly working for the NHS . Medical reports must be provided to patients in accordance with current legislation, and, at the patient’s request, they will be delivered either in a sealed envelope or electronically to the address provided. With the patient’s consent, the pharmacies may forward the report(s) to the patient’s doctor.

Resolution facing opposition

The Association of Independent Healthcare Companies (AISI) and several operators in the sector, such as medical laboratories accredited with the NHS, recently appealed the Resolution before the Regional Administrative Court standing in stark contrast with the possibility of carrying out diagnostic tests in pharmacies without effective and direct medical supervision.

In particular, according to AISI, the Resolution creates an unregulated overlap between the activities of accredited facilities and those of pharmacies. This not only undermines the proper management of public resources, but also paves the way for unfair competition, considering that pharmacies can access trials with simplified procedures and without the same guaranteed requirements as healthcare facilities. In addition to organizational and economic issues, according to AISI there is also concern about the possible decrease of the quality of medical reporting and care.

Furthermore, the appeals also address procedural and accounting issues, as well as issues related to health and hygiene control of the facilities. According to the appealers in fact the Resolution does not allow a proper and effective prior verification of the structural and professional requirements of pharmacies since the space and equipment requirements (e.g the existence of dedicated areas of no less than 5 square meters) are left to the self-certification of pharmacies’ owners and no penalties are provided for any non-compliance. According to the appealer this would breach Article 8-quinquies of Legislative Decree 502/1992, which requires external control procedures to verify the appropriateness of healthcare services.

Based on publicly available information, the Court rejected the appellants’ request for a precautionary suspension of the Resolution, as it was deemed that there weren’t the conditions of extreme gravity and urgency required to grant the suspension. The hearing to discuss the matter is now scheduled for December 2^nd.

Impact of the resolution

This Resolution certainly sets an important precedent for the enhancement of the Service Pharmacy, bringing healthcare closer to citizens and reducing congestion in healthcare facilities. Moreover, similar initiatives – that we expect will be implemented soon also in other Regions – open new interesting opportunities for pharmacies to develop and expand their businesses.

The trend to strengthen the pharmacies’ role is also confirmed by two very recent regulatory news: indeed, the Council of Ministers has recently approved two draft laws enhancing the role of pharmacies in delivering health and telemedicine servicesthe new draft of the “Consolidated law on pharmaceuticals” was approved on September 18 2025, strengthening the role of local pharmacies by encouraging them to play an active part in new forms of healthcare delivery, such as telemedicine and remote monitoring.

[1] The trial has been introduced by Law 205/2017 and refinanced by Law 215/2023 for the years 2024 and 2025.

[2] The concept of the “Pharmacy of Services” is introduced and regulated at national level by the Legislative Decree no. 153/2009 and refers to a local pharmacy that provides health services in addition to dispense medication.