{"title":"[New European Pharmaceutical Legislation: a challenge to reconcile public health protection and market competitiveness].","authors":"Emanuele Sbraga, Chiara Gerardi, Eleonora Allocati, Rita Banzi, Silvio Garattini","doi":"10.19191/EP25.2-3.A802.026","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>twenty years after the last review of the European Union (EU) pharmaceutical legislation, the pharmaceutical sector has significantly changed and become more globalised. Unmet medical needs and unequal access to innovative treatments persist. In addition, there is a growing awareness of the need for developing new antibiotics and a rational use of existing ones. In this context, in 2020 the European Commission proposed a new pharmaceutical strategy for Europe aiming to ensure equitable access to effective and safe medicines while strengthening the competitiveness of the sector globally. In line with this strategy, the Commission itself proposed a comprehensive reform of the pharmaceutical legislation in 2023, which was later amended by the European Parliament.</p><p><strong>Objectives: </strong>to analyse some of the main proposals for changes to the current regulatory framework and discuss their impact on European pharmaceutical policies and public health.</p><p><strong>Design: </strong>analysis of the current regulatory context on medicines and comparison with the main proposals of the European Commission and Parliament.</p><p><strong>Results: </strong>among the most significant reform proposals are: 1. the changes to data and market protection with the creation of a system of incentives to support innovation, promoting the development of safe and effective medicines and their access to patients, and making the EU attractive to the pharmaceutical companies; 2. the set of measures to incentivise the development of new antimicrobials and control antimicrobial resistance; 3. the measures aimed at increasing the transparency of the European Medicines Agency.</p><p><strong>Conclusions: </strong>this critical and independent analysis of the current draft reform of the pharmaceutical legislation shows important novelties that could deeply transform the current European regulatory framework of the pharmaceutical sector, highlighting some critical issues regarding the significance and effectiveness of some proposals. Once the entire legislative process has been completed, it will be possible to witness the implementation of the reform in its final version, which will require an assessment of its real impact.</p>","PeriodicalId":50511,"journal":{"name":"Epidemiologia & Prevenzione","volume":"49 2-3","pages":"190-199"},"PeriodicalIF":1.2000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Epidemiologia & Prevenzione","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.19191/EP25.2-3.A802.026","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
Abstract
Background: twenty years after the last review of the European Union (EU) pharmaceutical legislation, the pharmaceutical sector has significantly changed and become more globalised. Unmet medical needs and unequal access to innovative treatments persist. In addition, there is a growing awareness of the need for developing new antibiotics and a rational use of existing ones. In this context, in 2020 the European Commission proposed a new pharmaceutical strategy for Europe aiming to ensure equitable access to effective and safe medicines while strengthening the competitiveness of the sector globally. In line with this strategy, the Commission itself proposed a comprehensive reform of the pharmaceutical legislation in 2023, which was later amended by the European Parliament.
Objectives: to analyse some of the main proposals for changes to the current regulatory framework and discuss their impact on European pharmaceutical policies and public health.
Design: analysis of the current regulatory context on medicines and comparison with the main proposals of the European Commission and Parliament.
Results: among the most significant reform proposals are: 1. the changes to data and market protection with the creation of a system of incentives to support innovation, promoting the development of safe and effective medicines and their access to patients, and making the EU attractive to the pharmaceutical companies; 2. the set of measures to incentivise the development of new antimicrobials and control antimicrobial resistance; 3. the measures aimed at increasing the transparency of the European Medicines Agency.
Conclusions: this critical and independent analysis of the current draft reform of the pharmaceutical legislation shows important novelties that could deeply transform the current European regulatory framework of the pharmaceutical sector, highlighting some critical issues regarding the significance and effectiveness of some proposals. Once the entire legislative process has been completed, it will be possible to witness the implementation of the reform in its final version, which will require an assessment of its real impact.
期刊介绍：
Epidemiologia & Prevenzione, oggi organo della Associazione italiana di epidemiologia, raccoglie buona parte delle migliori e originali esperienze italiane di ricerca epidemiologica e di studio degli interventi per la prevenzione e la sanità pubblica.
La rivista – indicizzata su Medline e dotata di Impact Factor – è un canale importante anche per la segnalazione al pubblico internazionale di contributi che altrimenti circolerebbero soltanto in Italia.
E&P in questi decenni ha svolto una funzione di riferimento per la sanità pubblica ma anche per i cittadini e le loro diverse forme di aggregazione. Il principio che l’ha ispirata era, e rimane, che l’epidemiologia ha senso se è funzionale alla prevenzione e alla sanità pubblica e che la prevenzione ha ben poche possibilità di realizzarsi se non si fonda su valide basi scientifiche e se non c’è la partecipazione di tutti i soggetti interessati.
Modalità di comunicazione aggiornate, metodologia statistica ed epidemiologica rigorosa, validità degli studi e solidità delle interpretazioni dei risultati sono la solida matrice su cui E&P è costruita. A questa si accompagna una forte responsabilità etica verso la salute pubblica, che oggi ha ampliato in forma irreversibile il suo orizzonte, e include in forma sempre più consapevole non solo gli esseri umani, ma l’intero pianeta e le modificazioni che l’uomo apporta all’universo in cui vive.
L’ambizione è che l’offerta di nuovi strumenti di comunicazione, informazione e formazione, soprattutto attraverso l''uso di internet, renda la rivista non solo un tradizionale veicolo di contenuti e analisi scientifiche, ma anche un potente strumento a disposizione di una comunità di interessi e di valori che ha a cuore la salute pubblica.
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