Deblistering: current regulatory framework in light of the new opinion issued by the Council of State

Within this fragmented context, there have been both judicial and legislative developments that have provided important reference points for legitimizing the practice. Among these, the recent interlocutory opinion issued by the Council of State on December 11, 2024, appears to mark a further step forward in the complex and still uncertain framework.

The deblistering activity and the current legal framework

The deblistering consists in the activity of unpacking purchased medicines and repacking them into customised sachets or blister packs for patients, according to their doctor’s prescription (usually in daily or weekly doses). This practice aims to provide personalised management of drug therapies for patients requiring chronic treatment: providing special personalised blister packs helps patients follow their treatment regimen without error, preventing them from forgetting to take certain drugs or confusing different packages. As of today, some pioneering Italian pharmacies offer deblistering as a service. This service is currently paid for entirely by the citizens, i.e. it is not reimbursed by the National Health Service (SSN) or the Regional Health Service (SSR).

Although Italy has not yet adopted comprehensive legislation regulating deblistering at national level, there are several legal provisions and case law that may serve as the foundation of this practice:

• First, Law no. 189/2012 authorizes Regions to trial repackaging systems, including customized ones, and systems for distributing medicines to patients undergoing treatment in hospitals and healthcare residential facilities, in order to eliminate product waste and the risk of errors and improper use. According to this norm, the unpacking and repackaging of medicines shall be carried out in accordance with Good Manufacturing Practice, indicating the original batch number and expiry date.
• Next, Law no. 190/2014 (2015 Stability Law) in paragraphs 591-592, on an experimental basis for a two-year period, opens the possibility of identifying methods for the production and distribution of single-dose medicines in hospitals.
• Finally, Law 160/2019 (2020 Budget Law) represents the legal basis for the carry-out of deblistering in pharmacies. In particular, the 2020 Budget Law affirms the possibility of using a personalised access service for medicines at pharmacies, in collaboration with general practitioners and pediatricians of choice and in accordance with medical prescriptions^[1].

Deblistering activities in pharmacies

With specific regard to deblistering in pharmacies, although the 2020 Budget Law took step forward in recognizing the possibility for pharmacists to carry out deblistering activity, it raises a number of questions and potential issues that need to be addressed. In particular, the law does not specify the conditions under which this practice must be carried out, and how deblistering activities can be initiated. To fill these gaps, some regions (most notably Lombardy, Veneto, Emilia-Romagna, and Umbria)^[2] have intervened to regulate deblistering in pharmacies and healthcare facilities, adopting guidelines regulating the practice of deblistering locally. The Lombardy Region circular is a noteworthy precedent, having paved the way for the practice in Italy.

According to the Lombardy Region circular, pharmacies must notify the competent local health authority when they begin deblistering activities. Pharmacies carrying out deblistering must put in place appropriate procedures and comply with certain rules concerning the management of medicines, packaging of blister packs, as well as the places to carry out the activity. The circular also specifies that deblistering must be carried out only by pharmacists as they are healthcare professionals with expertise in medicines, but this may also apply in hospitals and nursing homes. If pharmacists are unable to perform the service themselves, they are required to supervise the work carried out by other operators and are responsible for the preparation procedures.

In light of the above-mentioned framework, the absence of national legislation prevents the possibility for patients and healthcare operators/pharmacies to have a clear reference point for the exercise of deblistering activity. Indeed, the fact that only some regions have laid down rules through administrative acts (mostly circulars), while others have not established anything in this regard, has created confusion across the country.

Despite the uncertainty created by the fragmented regulatory framework, a recent interlocutory opinion by the Council of State arising from a recent case of 2022 is hoped to prompt the Ministry of Health to intervene to regulate deblistering once and for all and establish clear rules for its conduct.

The Council of State’s Opinion of December 11, 2024

The case stems from an extraordinary appeal to the President of the Republic filed by Farmacie Pesce S.p.A., which, on 25 August 2022, notified the local health authority (ASL TO5 – “ASL”) of its intention to begin deblistering activities. The petitioner claimed that its activities were in compliance with Lombardy’s regional guidelines. The ASL issued a negative opinion, arguing that there was no detailed national legislation on the matter and that the Piedmont Region had not adopted its own guidelines. ASL also notified the negative opinion of the Region, which aligned with the assessments of the ASL.

The petitioner requested the annulment of the ASL TO5 opinion and the recognition of its right to carry out the deblistering activity. For this purpose, the petitioner relied on article 3 of the Legislative Decree no. 219/2006 (“Italian Medicine Code”), which explicitly excludes the necessity to obtain marketing authorization for so-called galenic medicines, that is, medicines prepared in a pharmacy based on a medical prescription for an individual patient, known as magistral formulas. The petitioner argued that, since no administrative authorization or prior approval is required for galenic preparations — as confirmed by case law (see Council of State, Section III, 9 January 2017, No. 24) — and the pharmacist may prepare them within the pharmacy in compliance only with Good Manufacturing Practices under national and European law, then the same legal framework must apply to deblistering. According to the petitioner, in such cases, the pharmacy does not alter the active ingredients in any way but simply removes the medicines from their original packaging and places them into customized blister packs.

The Ministry of Health intervened in the proceedings and supported the ASL’s position, arguing that in the absence of a general legal framework regulating deblistering, the activity is only permitted in cases explicitly allowed by law (mainly according to the Law n. 189 of 2012 and Budget Law n. 190 of 2014 which allows the possibility to carry out deblistering activity under specific conditions and in the hospital setting). According to the Ministry, deblistering activities that are carried out under these specific regulations must be authorized as they fall with the scope of article 6 of the Italian Medicine Code. More specifically, this provision states that any additional dosage, pharmaceutical form, route of administration, or presentation, as well as any variations and extensions of a medicine must be subject to authorization. On these grounds, the Ministry concluded that pharmacies may carry out deblistering only if expressly authorized (in this regard, according to the Ministry of Health the authorization and oversight of the deblistering service could fall within the competence of the Italian Medicine Agency – AIFA), but in the case at issue deblistering at the petitioner’s pharmacy could not be carried out as an authorization was not granted.

According to the Opinion of the Counsil of State (but also as noted by the Ministry itself) deblistering is not specifically governed by the current legal framework, but it is also neither prohibited by law, nor deemed harmful to public health, nor subject to objections from the competent supervisory authorities regarding regional resolutions that have regulated the practice. However, considering the sensitive nature of the matter and the fact that is already commonly practiced by many pharmacies and explicitly regulated by some Italian Regions, the Council of State adopted a cautious approach asking the Ministry of Health to carry out an appropriate analysis of the activity.

The Court in fact requests the Ministry to provide a detailed report (in addition to the one already requested during the proceedings), and that all relevant documents be submitted within 60 days of receipt of this interlocutory opinion, and that must address: (i) the regional regulations currently in place; (ii) any potential public health risks; (iii) the possible financial impact on the national health system.

New possible regulatory pathway for deblistering?

With this Opinion the Council of State appears inclined to consider deblistering a legitimate practice. Despite an opening signal, as aforementioned, the Council adopted a cautious approach — as often occurs in the absence of legislative action — by attempting to “construct” through the collaboration of the Ministry of Health legal pathways that promote a desirable evolution of the practice. Through deblistering, pharmacies are in fact able to further support therapeutic adherence and treatment effectiveness: repackaging facilitates the substitution with generic medicines, and the patient no longer receives multiple boxes but rather an appropriately prepared sachet or customized blister pack.

The Ministry’s response is expected to be reviewed by the judges in the following months, with a final decision to follow through the extraordinary appeal to the President of the Republic. The hope shared by those who view deblistering as a tool for improving therapeutic adherence is that this legal dispute will lead to a ruling that finally clarifies the legitimacy of the activity and triggers a regulatory update to resolve the inconsistencies among protocols adopted by some regions. This would establish uniform rules — both concerning the administrative procedure to be followed for initiating the activity (whether an authorization or a simple notification is required), and the conditions under which the competent operators (e.g. pharmacists or other healthcare professionals) may carry out the activity.

[1] In this regard, already in 2015, the Council of State, with Judgment no. 4257/2015 pronounced favorably on the possibility for pharmacies to carry out the repackaging industrial medicines for using it in the preparation of magistral preparations in specific and documented cases, allowing pharmacists to make available, for therapeutic purposes, formulations in orphan forms and dosages.

[2] Circular of the Lombardy Region no. 7474/2022; Resolution of the Veneto Region n. 423 /2024; Resolution of the Umbria Region n. 498/2024; Resolution of the Emilia Romagna Region n. 1335 /2024