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The operating rules on the white electronic prescription in the technical specifications of the health card system updated in mid-January and confirmed by the Lazio TAR ruling
Drugs classified as SOP and OTC cannot be prescribed on the same e-prescription as drugs classified as prescription-only. This is sanctioned by the technical specifications of the health card system, in the mid-January update, and confirmed by the sentence of the Lazio Regional Administrative Court at the end of May, which notes how, in this way, it is guaranteed that “the patient can buy drugs that are not subject to medical prescription” equally “at pharmacies or parapharmacies”, being able to “freely choose the operator”, without “recognizing a difference in treatment between pharmacies and parapharmacies”.
White electronic prescription in parapharmacy: the crux of the mixed prescription
The sentence (n. 9144 of 30 May 2023) stems from the appeal brought by some parapharmacies of various regions for the annulment of the Decree of the Ministry of Economy and Finance in agreement with the Ministry of Health of 1 December 2022 – amending of the decree of 30 December 2020 of the Ministry of Economy and Finance – “in the part in which it is expected that the SAC will make the functions for displaying and managing the blank electronic prescription available to the parapharmacy containing only drugs not subject to the obligation of a medical prescription ( SOP and/or OTC)”, without allowing, however, “the visualization of the mixed REB which contains in the same document, the indication of drugs not subject to medical prescription and that of drugs subject to medical prescription”.
The story, reads the sentence, “grafts on to a series of other disputes still pending between the parties”. In particular, previously, some parapharmacies, regarding the start of the dematerialization of the white prescription, with an application dated May 23, 2022, had “asked the Ministry of Economy and Finance and the Ministry of Health to provide for the necessary formalities so that it granted them access to the telematic platform of the Health Card System Service (STS) in order to be able to read the electronic blank prescriptions (REB) through which general practitioners prescribe drugs and products that can be purchased by patients also from their businesses, a possibility which to date is precluded to them”. Faced with the “silence of the administrations”, they took legal action before the Lazio Regional Administrative Court, which, with the related “judgment of 2 November 2022, n. 14273, found that the failure to connect the parapharmacies to the STS did not allow them to be able to sell through the recipe transmission channel (REB) – and beyond the traditional oral request channel – the products that they were authorized by law to commercialize”. The appeal was accepted and, “following the sentence, the MEF, in concert with the Ministry of Health, adopted the decree of 1 December 2022, which integrated the system for the dematerialisation of prescriptions not covered by the Health Service national”, adding the article which was then the subject of dispute.
To be raised, with the subsequent appeal, is precisely the question of the visualization and management of the mixed REB.
With the ruling of the Tar remember the operational changes
According to the College, the ministerial decree in question is not in itself “affected by the illegitimacy reported”. The Board recalled “the changes made by the MEF and SOGEI to the STN of the REB”. In particular, “the technical specifications – in the version dated January 17, 2023 – provide for the doctor to block the technical block in generating a blank dematerialized prescription for a mixed prescription containing both drugs classified as prescription-only and drugs classified as non-prescription (SOP and OTC). Therefore, in the case of mixed prescriptions, the computer system will allow the doctor to produce distinct dematerialized prescriptions and this in order to ensure that the drugs classified as non-prescription (SOP and OTC) are present on a usable dematerialized prescription freely chosen by the patient both in the parapharmacy and in the pharmacy. The computer system therefore does not allow the generation of a blank dematerialized prescription with a mixed prescription”. For the panel, these changes “highlight how the ministerial decree of 1 December 2022 now respects, in practice, the discipline established by the legislator on the sale of SOP and OTC medicines. That is, “the perfect equivalence of the display of mixed white recipes” by the pharmacies and parapharmacies”. In fact, from 18 January pharmacies are effectively barred from viewing and managing the so-called mixed REBs, thus aligning their position with that of the parapharmacy. The REB containing only non-prescription drugs can now be viewed and managed by both the pharmacy and the parapharmacy, as both commercial establishments are authorized by law to sell these products. The assisted person, upon presentation of the REB, will then be able to purchase medicines not subject to medical prescription at pharmacies and/or parapharmacies”.