Medicines pricing conditions in Italy and Brazil: comparison of regulations

Genéricos/Investigación | Posted 26/08/2022 post-comment0 Post your comment

In the context of the National Health Services (NHS), the gearing that moves the health services comprises a legal framework, permeated by technical and economic parameters.

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Among the health services offered in most countries, the pharmaceutical service is the most susceptible to change because it depends on provisions from the financial legal framework, based on monitoring the flow of medicines distribution, prescription and procurement [1, 2].

In this sense, the medicines pricing in Italy considers the internal reference price (IRP), in addition to analysing the scientific evidence regarding the efficacy and safety of each medicine that has been granted marketing authorization in the country. Through quality scientific evidence evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, both the therapeutic need and value must be proven. The therapeutic need is determined since the efficacy and safety of the medicine are reviewed in relation to other available medicines in the market. While the therapeutic value is assessed by the magnitude of the clinical benefit when compared with the available alternatives, based on clinically recognized, relevant and validated outcomes for the pathology in question [3-7].

A supplementary analysis for pricing is carried out through the external reference price (ERP). In Italy, the prices of 24 European countries are used as a guide for pricing and reimbursement negotiations [3].

The aim of a case study, carried out by Brazilian and Italian researchers, was to analyse how the pricing and reimbursement processes are carried out in Italy, in order to seek subsidies to support discussions on the reassessment of Brazilian legislation [8].

The results showed some common points between Brazilian and Italian pricing legislation. For example, in both regulations there is no definition for innovation of a medicine, that is, there is no relationship between price with innovation status. Both pricing processes also take into account the health technology assessment and reports, with the results of scientific evidence related to efficacy, safety and therapeutic need based on valid outcomes for pathologies assisted by existing medicines, or not, in the market. In addition, the IRP and the ERP are considered in the assessment of pricing of medicines. The IRP considers, among other items, the prices and sales volumes of other competing drugs, from the same company and from the market. The ERP considers price conditions in other countries.

However, some criteria that are different between legislations and that deserve to be evaluated within the Brazilian reality are:
• Italian regulations demand that generic and biosimilar medicines enter into the market with a price at least 20% lower than the originator.
• Review of negotiated prices can occur at any time, whether due to new evidence of efficacy and safety arising from the pharmacovigilance system or upon request for changes in the therapeutic indications and/or dosage. The established legal period for price review is by default 24 months, 36 months for innovative medicines and 18 months for conditionally (or potentially) innovative medicines [5-7, 9].

Conflict of interest
The authors of the research paper [8] declared that there was no conflict of interest.

Abstracted by Valdete Aparecida de Melo, Executive-Secretariat of the Drug Market Regulation Chamber (SCMED); Brazilian Health Regulatory Agency (ANVISA), Brasília, Brazil.

Editor’s Comment
Readers interested to learn more about biosimilars in Brazil are invited to visit to view the following manuscript published in GaBI Journal:

First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society

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1. Ministero della Salute. Direzione Generale della digitalizzazione del Sistema Informativo Sanitario Annuario statistico del servizio sanitario nazionale. 2019 [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
2. Agenzia Italiana del Farmaco. Osservatorio sull’impiego dei medicinali (OsMed). 2021 [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
3. Pharmaceutical Pricing and Reimbursement Information. PPRI Pharma Brief: Italy 2021. [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
4. Agenzia Italiana del Farmaco. Prezzi e rimborso [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
5. Agenzia Italiana del Farmaco. Criteri per la classificazione dei farmaci innovativi e dei farmaci oncologici innovativi ai sensi dell’articolo 1, comma 402, della legge 11 dicembre 2016, n. 232.; 2017:519. [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
6. Agenzia Italiana del Farmaco. Farmaci innovativi [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
7. Agenzia Italiana del Farmaco. (Allegato 1. Criteri per la valutazione dell’innovatività. 2017 [homepage on the Internet]. [cited 2022 Aug 26]. Available from:
8. Melo VA, Ascef BO, Gianfrate F. Italy – a study case of medicines pricing and reimbursement. Rev Bras Farm Hosp Serv Saude 2022;13(2):0814.
9. Gazzetta Ufficiale della Repubblica Italiana. Individuazione dei criteri per la contrattazione del prezzo dei farmaci. (Deliberazione n. 3/2001). (GU Serie Generale n.73 del 28-03-2001).

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