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[Summer mortality: evaluating the effects of the June 2025 heatwave in Italy]. [夏季死亡率:评估2025年6月意大利热浪的影响]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-07-01 DOI: 10.19191/EP25.4.A911.061
Paola Michelozzi, Francesca de'Donato, Pasqualino Rossi, Sergio Iavicoli
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引用次数: 0
[Agreement between health care claims and the physician's follow-up visits in the determination of post-transplant immunosuppressive therapies: the CESIT study]. [医疗保健声明与医生随访在移植后免疫抑制治疗确定方面的一致性:CESIT研究]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-07-01 DOI: 10.19191/EP25.4.A849.075
Alessandro Cesare Rosa, Marco Finocchietti, Arianna Bellini, Lucia Masiero, Pamela Fiaschetti, Ilaria Lombardi, Andrea Ricci, Massimo Cardillo, Giuseppe Feltrin, Silvia Pierobon, Martina Zanforlini, Stefano Ledda, Valeria Belleudi
<p><strong>Background: </strong>maintenance immunosuppressive therapy, indicated for patients after solid organ transplantation - kidney (R), liver (F), heart (C), lung (P) - and aimed at preventing rejection, involves the intake of at least one Calcineurin (CNI) inhibitor (Cyclosporin - CsA - or Tacrolimus - TAC) in combination with an Antimetabolite (Antim) (Mycophenolate Mofetil or Mycophenolic Acid - MMF - or Azathioprine - AZA) or a proliferation signal inhibitor (mTOR) (Sirolimus - SIR - or Everolimus - EVE) with the possible addition of corticosteroids (in particular Prednisone - PRED). The possibility of comparing prescribing patterns identified through different data sources represents an important methodological challenge and could shed light on the accuracy, advantages, and limitations of different information sources, aspects that must be considered when planning future observational studies.</p><p><strong>Objectives: </strong>to assess, within a cohort of solid organ transplant patients, the levels of concordance in the definition of post-transplant immunosuppressive therapy between health administrative flows and what is reported by the medical specialist during the patient's periodic follow-up visit.</p><p><strong>Design: </strong>analysis of the level of concordance of information on post-transplant maintenance immunosuppressive therapy collected from two different data sources: the regional health administrative databases (SIS) and the national transplant information system (SIT). This analysis was performed as part of a retrospective cohort study - the CESIT study - including all patients undergoing single solid organ transplantation (heart, liver, lung, kidney) between 2009 and 2019 in four Italian regions (Lombardy, Lazio, Veneto, Sardinia). The therapeutic combinations of immunosuppressants were identified by means of specific algorithms applied to the SIS data and subsequently compared with the therapeutic patterns recorded by specialist physicians during follow-up visits (FU) and entered electronically in the SIT flow sheets. The analysis focuses mainly on the therapy delivered in the 30 days following hospital discharge (index therapy); it is then extended to comparisons made over longer time windows (at 1, 2, and 3 years from the date of hospital discharge).</p><p><strong>Main outcome measures: </strong>the level of agreement between the two data sources in defining the index therapy was assessed using three methods: 1. Cohen's k statistic: this method allowed quantification of the level of agreement at the level of individual active substance; 2. proportion of active ingredients in common: an ordinal categorical variable was calculated for each patient indicating the level of concordance between the sources: null (no active ingredient in common), low (<40 % of ATCs in common), medium (40-59 %), high (>60 %), perfect (identical combinations); 3. Levenshtein distance (LS): considering polypharmacies from a formal point of
背景:维持免疫抑制治疗,适用于实体器官移植后的患者-肾(R),肝(F),心(C),肺(P) -旨在预防排斥反应;包括摄入至少一种钙神经磷酸酶(CNI)抑制剂(环孢素- CsA -或他克莫司- TAC)联合抗代谢物(Antim)(霉酚酸酯或霉酚酸- MMF -或硫唑嘌呤- AZA)或增殖信号抑制剂(mTOR)(西罗莫司- SIR -或依维莫司- EVE),并可能添加皮质类固醇(特别是泼尼松- PRED)。比较通过不同数据源确定的处方模式的可能性是一项重要的方法学挑战,可以揭示不同信息来源的准确性、优势和局限性,这些是规划未来观察性研究时必须考虑的方面。目的:在一组实体器官移植患者中,评估健康管理流程与医学专家在患者定期随访期间报告的移植后免疫抑制治疗定义之间的一致性水平。设计:分析从区域卫生管理数据库(SIS)和国家移植信息系统(SIT)这两个不同数据源收集的移植后维持免疫抑制治疗信息的一致性水平。该分析是一项回顾性队列研究(CESIT研究)的一部分,该研究包括2009年至2019年在意大利四个地区(伦巴第、拉齐奥、威尼托、撒丁岛)接受单一实体器官移植(心、肝、肺、肾)的所有患者。免疫抑制剂的治疗组合通过应用于SIS数据的特定算法确定,随后与专科医生在随访(FU)期间记录的治疗模式进行比较,并以电子方式输入SIT流程表。分析主要集中在出院后30天内的治疗(指标治疗);然后将其扩展到更长的时间窗(从出院之日起1年、2年和3年)进行比较。主要结局指标:使用三种方法评估两个数据源在定义指标治疗方面的一致性水平:1。Cohen’s k统计量:该方法可以量化个体活性物质水平上的一致性水平;2. 共同有效成分的比例:为每个患者计算一个顺序分类变量,表明来源之间的一致性水平:零(无共同有效成分),低(60%),完全(相同的组合);3. Levenshtein距离(LS):从形式化的角度将多药房视为字符串,估计使它们相等所需的计算量。结果:有2692例实体器官移植患者可获得SIS和SIT的指标治疗信息(C: 6.8%; F: 44.9%; P: 5.2%; R: 43.1%)。与CNI免疫抑制剂相比,Cohen’s k系数在所有移植类型中显示出高水平的一致性(CsA心脏:0.78,CsA肝脏:0.96 - TAC心脏:0.74,TAC肾脏:0.92);而对于MMF,不同器官类型的表现差异明显(MMF心脏:0.51;MMF肾脏:0.78)。对于Preds来说,在R和F方面存在更大的不一致性。当将免疫抑制治疗作为一个整体进行比较时,平均80.1%的患者存在“高/完美”一致性水平(F: 70.1%; R: 91.3%)。应用LS的结果具有可比性。最后,出院后1年、2年和3年的一致性报告不如指数治疗好,然而,在考虑的时间间隔内,指数治疗是稳定的。结论:在不同来源检测到的同一患者的治疗组合之间的一致性水平普遍较高:尽管如此,一致性水平因个体活性物质、移植类型和检查的时间窗而异。这项工作的结果表明,SIS是定义免疫抑制维持疗法的一个有价值的工具,并在计划基于这两种数据流的观察性研究时提供了有用的考虑因素。
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引用次数: 0
[Interesting new findings on the relationship between PFAS and congenital malformations]. [关于PFAS与先天性畸形之间关系的有趣新发现]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-07-01 DOI: 10.19191/EP25.4.A908.065
Fabrizio Bianchi
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引用次数: 0
[Pneumococcal vaccination recommendations in at-risk adults and people aged 65 years or over across the Italian regions: a mapping review]. [意大利各地区高危成人和65岁及以上人群的肺炎球菌疫苗接种建议:制图回顾]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-07-01 DOI: 10.19191/EP25.4.A848.068
Francesca Fortunato, Domenico Martinelli, Valeria Gabellone, Elisa Gabrielli, Fabiana Nuccetelli, Rosa Prato
<p><strong>Objectives: </strong>to review pneumococcal vaccination recommendations in at-risk adults and people aged 65 years or over across the Italian Regions.</p><p><strong>Design: </strong>mapping review of available online resources, both at regional and local health unit level, on pneumococcal vaccination programmes by age and risk group.</p><p><strong>Setting and participants: </strong>the review included institutional websites of regional and local health authorities, freely accessible to the public via generic search engines, containing information on pneumococcal vaccination in frail people.</p><p><strong>Main outcome measures: </strong>the following information was collected and classified: • populations targeted by the immunization programme; • type of recommended vaccine (conjugate and/or polysaccharide); • adopted vaccination schedule; • mode of patient contact; • involved health professional; • availability of vaccination registry; • availability of vaccination coverage data; • presence of online awareness campaigns.</p><p><strong>Results: </strong>a total of 24 institutional websites, representative of all Italian Regions, were included in the review. More than 90% of the recommendations collected were published between 2023 and 2024. In 75% of the analyzed documents, the Regions offer pneumococcal vaccination to the cohort aged 65 years; in 46% of the documents, the offer is extended to all persons aged 65 years and over. In 96% of the resources, the vaccination programme includes at-risk adults, and 75% of these give details of the diseases for which vaccination is recommended. In seven resources, it is reported that Regions recommend a single dose of the 20-valent pneumococcal conjugate vaccine, in the others the use of the pneumococcal conjugate vaccine (PCV) followed by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) is indicated, with different schedules. In at-risk adults, 83% of the documents recommend the sequential schedule with PCV followed by PPSV23, with time schedules defined in 63% of cases. The mode of patient contact is reported in 7 web resources, 4 of which include sending an invitation letter at 65 years of age. Vaccination center health professionals (16/24) and general practitioners (15/24) are the healthcare providers most involved in promoting and administering vaccination. In 71% of the resources, the regional health authorities were reported to have promoted targeted communication campaigns. Data on PCV coverage by age were available for 6 Regions, but not by risk group.</p><p><strong>Conclusions: </strong>the findings of this study highlight significant heterogeneity in the offer of pneumococcal vaccination to at-risk adults and people aged 65 years and older among Italian Regions. Greater efforts are needed to standardize and harmonize vaccination policies and to coordinate vaccination communication. The integration of immunization registries with high-risk patient clinical data will allow th
目的:回顾意大利各地区高危成人和65岁以上人群的肺炎球菌疫苗接种建议。设计:对区域和地方卫生单位一级按年龄和风险群体划分的肺炎球菌疫苗接种规划的现有在线资源进行制图审查。环境和参与者:审查包括区域和地方卫生当局的机构网站,公众可以通过通用搜索引擎免费访问这些网站,其中包含有关体弱人群肺炎球菌疫苗接种的信息。主要成果措施:收集并分类了以下信息:•免疫规划针对的人群;•推荐的疫苗类型(结合疫苗和/或多糖);•采用疫苗接种时间表;•患者接触方式;•参与的保健专业人员;•疫苗接种登记的可用性;•疫苗接种覆盖率数据的可用性;•在线宣传活动的存在。结果:共有24个机构网站,代表所有意大利地区,被纳入审查。收集到的建议中有90%以上是在2023年至2024年之间发表的。在75%的分析文献中,各地区为65岁人群提供肺炎球菌疫苗接种;在46%的文件中,这项优惠扩大到所有65岁及以上的人。在96%的资源中,疫苗接种方案包括有风险的成年人,其中75%提供了建议接种疫苗的疾病的详细信息。据报道,在7个资源中,各区域建议使用单剂20价肺炎球菌结合疫苗,在其他资源中,建议使用肺炎球菌结合疫苗(PCV),然后使用23价肺炎球菌多糖疫苗(PPSV23),时间表不同。在高危成人中,83%的文献推荐PCV和PPSV23的顺序治疗方案,63%的病例确定了时间表。7个网络资源报告了患者接触方式,其中4个包括在65岁时发送邀请函。疫苗接种中心的卫生专业人员(16/24)和全科医生(15/24)是在促进和管理疫苗接种方面参与最多的卫生保健提供者。据报告,在71%的资源中,地区卫生当局促进了有针对性的宣传运动。有6个地区按年龄分列的PCV覆盖率数据,但没有按风险组分列的数据。结论:本研究的结果突出了意大利地区对高危成人和65岁及以上人群提供肺炎球菌疫苗接种的显著异质性。需要作出更大努力,使疫苗接种政策标准化和协调一致,并协调疫苗接种交流。将免疫登记与高风险患者临床数据相结合,将有助于系统地确定候选疫苗,并促进对疫苗接种覆盖率的监测。
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引用次数: 0
Juvenile detention in Italy: from a model of protection admired throughout Europe to a criminalising and pathogenic place. 意大利的青少年拘留:从全欧洲推崇的保护模式到犯罪和致病之地。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-07-01 DOI: 10.19191/EP25.4.081
Nicola Cocco

Juvenile prisons represent a jumble of dilemmas and choices for those concerned about the health and future of young detained people. While often presented as an opportunity for "rescue" and even social redemption, juvenile justice facilities offer a variety of approaches, ranging from the more advanced ones that allow effective interactions with the "outside" (family, school, and the world of work) to the more closed ones where the lack of support and activities exposes the most serious aspects of any incarceration: violence, isolation, and various forms of addiction. Italy's main and largest juvenile prison, named after Cesare Beccaria (an Italian philosopher universally renowned for laying the conceptual foundations against the death penalty and torture), has been experiencing a period of great difficulty for years, characterized by widespread violence, inadequate care for the needs of young people in prison, staff frustration, and social criminalization of inmates, accompanied by the stigmatization of those who work there. The author analyses the risks for young people detained in such places and invites to reflect about what general conclusions can be drawn about juvenile prisons in today's Italian society.

对于那些关心青少年被拘留者的健康和未来的人来说,少年监狱是一个混乱的困境和选择。虽然青少年司法设施经常被视为“拯救”甚至社会救赎的机会,但它提供了各种各样的方法,从允许与“外部”(家庭、学校和工作世界)进行有效互动的更先进的方法到更封闭的方法,在这些方法中,缺乏支持和活动暴露了任何监禁的最严重方面:暴力、孤立和各种形式的成瘾。意大利主要和最大的少年监狱以切萨雷·贝卡利亚(Cesare Beccaria,意大利哲学家,因提出反对死刑和酷刑的概念基础而闻名)的名字命名。多年来,该监狱经历了一段非常困难的时期,其特点是暴力现象普遍存在,监狱中年轻人的需求得不到充分照顾,工作人员感到沮丧,囚犯被社会定为犯罪,同时监狱工作人员也被污名化。作者分析了被关押在这些地方的年轻人所面临的风险,并请大家反思一下,在今天的意大利社会中,关于少年监狱可以得出什么一般性结论。
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引用次数: 0
[Global Glyphosate Study: new evidence on carcinogenic effects of glyphosate and glyphosate-based pesticides]. [全球草甘膦研究:关于草甘膦和基于草甘膦的农药致癌作用的新证据]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-07-01 DOI: 10.19191/EP25.4.069
Daniele Mandrioli, Simona Panzacchi
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引用次数: 0
[Smart working and active mobility for reducing CO2 emissions from the home-to-work commute: the results of the Climactions project]. [减少从家到公司通勤的二氧化碳排放的智能工作和主动机动性:Climactions项目的结果]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-03-01 DOI: 10.19191/EP25.2-3.S1.053
Lisa Bauleo, Francesca de'Donato, Manuela De Sario, Paola Michelozzi, Carla Ancona

Objectives: to estimate CO2 emissions for different commuting modes before, during, and after the COVID-19 lockdown, and define scenarios to assess their impact on the environment and health.

Design: cross-sectional study using data retrieved from a survey.

Setting and participants: the study included anonymous participation from both researchers involved in the Climactions project and the general population; the questionnaire was made available through social media. Information was gathered on the transportation modes used to commute, the distance travelled and travel times before, during, and after the COVID-19 emergency, and proposals for actions/solutions to enhance sustainable commuting in urban areas.

Main outcome measures: the amount of CO2 emissions due to different commuting modes during various stages of the pandemic was estimated based on vehicle-specific emission coefficients provided by the European Environmental Agency, taking into account the average number of passengers per vehicle. Sustainable commuting scenarios were also proposed, including active transportation (walking, cycling, etcetera).

Results: the online questionnaire was filled-in by 2,904 persons, predominantly women (62.3%) and residents in Northern Italy (44.6%). Over 80% of the respondents were aged over 40 (0.7% <25 years). On average, the distance travelled on a daily commute was 23.6 km (median: 13 km), with longer distances in the Southern Regions (average: 38.2 km, median: 20 km). The average per-capita CO2 emissions were 2 kg per day in the pre-pandemic situation. The reduction in commuting during lockdown periods led to a significant decrease in estimated CO2 emissions, with an average per capita reduction of about 100 grams per day. From September 2020, the increase in smart working among respondents still allowed for a reduction in estimated CO2 levels, despite an increase in emissions from private vehicle use (1.5 kg per capita per day). Considering sustainable scenarios, a 15-minute walk during the daily commute would lead to a reduction in estimated CO2 levels of up to 0.7 kg per capita per day. Regarding the statement that "improving air quality in cities and reducing greenhouse gas emissions are useful actions to combat climate change", 94% of respondents strongly agreed.

Conclusions: in Italy, road transport accounts for approximately 25% of the total CO2 emissions. The lockdown provided a natural scenario for reducing emissions in urban areas, and the implementation of smart working was associated with a decrease in CO2 emissions due to reduced commuting. However, it is crucial to promote sustainable and active transportation modes for daily commuting such as walking and cycling, also considering the significant health co-benefits.

目标:估计在新冠肺炎封锁之前、期间和之后不同通勤模式的二氧化碳排放量,并确定情景,评估其对环境和健康的影响。设计:采用调查数据的横断面研究。环境和参与者:该研究包括参与气候项目的研究人员和普通人群的匿名参与;该问卷是通过社交媒体发布的。收集了在COVID-19紧急情况发生之前、期间和之后用于通勤的交通方式、行驶距离和出行时间的信息,以及为加强城市地区可持续通勤而提出的行动/解决方案建议。主要成果措施:根据欧洲环境署提供的车辆特定排放系数,考虑到每辆车的平均乘客人数,估算了大流行期间不同通勤模式造成的二氧化碳排放量。可持续的通勤场景也被提出,包括主动交通(步行、骑自行车等)。结果:在线问卷共有2904人填写,主要是女性(62.3%)和意大利北部居民(44.6%)。超过80%的受访者年龄在40岁以上(0.7%)。结论:在意大利,道路运输约占二氧化碳总排放量的25%。封锁为减少城市地区的排放提供了一个自然的方案,智能工作的实施与减少通勤导致的二氧化碳排放减少有关。然而,促进可持续和积极的日常通勤交通方式至关重要,如步行和骑自行车,同时考虑到显著的健康协同效益。
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引用次数: 0
[Climactions project: document review of policies and measures of climate change adaptation and mitigation in urban areas]. [气候项目:对城市地区适应和减缓气候变化的政策和措施的文件审查]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-03-01 DOI: 10.19191/EP25.2-3.S1.037
Manuela De Sario, Francesca de'Donato, Paola Michelozzi

Background: public health aims to promote a health-centred approach in all policies, even in adaptation and mitigation policies for climate change.

Objectives: to provide a critical summary on legislations, policies and case studies at international, national and local level and to assess the implementation of the "health lens", in support of researchers and workers on environment and health.

Design: document review on legislations, policies and case studies, focusing on mitigation of urban health island and sustainable mobility.

Methods: a policy and legislation review was carried out from institutional websites at European and local level. Sustainable urban mobility plans (SUMP) and energy and climate action plans (SECAP) were retrieved for the cities included in the Climactions project (Genoa, Turin, Bologna, Rome, Bari, Palermo) from local authorities' websites. Best practices of urban heat island mitigation and sustainable mobility were searched from European platforms (Climate adapt, Urban mobility observatory -- ELTIS, EIT Urban Mobility) to obtain a critical picture of adaptation and mitigation options in cities.

Results: the review shows a large number of legislations, plans, and programmes on adaptation and mitigation both at European and Italian level with a gap between planned and actually implemented actions also due to the lack of dedicated economic resources. There is also an inequal level of implementation among Italian regions, with some criticalities, for example, in the citizen participatory process within the strategic environmental assessment of SUMPs, SECAPs, and adaptation plans. At the local level, in the last decade, several best practices of urban heat island mitigation and sustainable mobility were experienced in different sectors including new urban green space infrastructures, albedo enhancement measures, car-pooling apps, incentives to active mobility, temporary streets liberation, and a combination of measures within adaptation plans such as London Climate Action Plan and Barcelona Superblock programme. Only few measures were health centred embedding public health into urban planning (e.g., the London plan based on the 'healthy streets' approach) suggesting health benefits for the population.

Conclusions: the recent increase in regulations and policies at European and national level is not paralleled by real progresses in climate actions, despite the constant growth of annual emissions. Therefore, there is the need to accelerate the fossil fuel emission mitigation while promoting adaptation to be ready to counteract actual and future climate related risks. Health workers such as paediatricians, family doctors, epidemiologists can advocate the transition and support the citizens and youth engagement in climate-related decision making.

背景:公共卫生的目标是在所有政策中,甚至在气候变化适应和减缓政策中,促进以健康为中心的做法。目标:提供关于国际、国家和地方各级立法、政策和案例研究的重要摘要,并评估“健康视角”的执行情况,以支持环境与健康方面的研究人员和工作人员。设计:对立法、政策和案例研究进行文件审查,重点是缓解城市健康岛和可持续流动性问题。方法:从欧洲和地方一级的机构网站进行政策和立法审查。可持续城市交通计划(SUMP)和能源与气候行动计划(SECAP)是从地方当局的网站上检索到的气候项目所包括的城市(热那亚、都灵、博洛尼亚、罗马、巴里、巴勒莫)。从欧洲平台(气候适应、城市机动性观察站——ELTIS、EIT城市机动性)搜索城市热岛缓解和可持续机动性的最佳做法,以获得城市适应和缓解备选方案的关键情况。结果:审查显示,欧洲和意大利有大量关于适应和缓解的立法、计划和方案,计划和实际执行的行动之间存在差距,这也是由于缺乏专门的经济资源。意大利各地区之间的执行水平也不平等,例如,在SUMPs、secap和适应计划的战略环境评估中的公民参与过程中存在一些关键问题。在地方一级,在过去十年中,城市热岛缓解和可持续交通的一些最佳做法在不同的部门得到了实践,包括新的城市绿色空间基础设施、反照率增强措施、拼车应用程序、积极交通的激励措施、临时街道解放,以及适应计划中的措施组合,如伦敦气候行动计划和巴塞罗那超级街区方案。只有少数措施以健康为中心,将公共卫生纳入城市规划(例如,基于“健康街道”方法的伦敦计划),表明对人口的健康有益。结论:尽管年排放量持续增长,但最近欧洲和国家层面法规和政策的增加并没有与气候行动的实际进展同步。因此,有必要加快减缓化石燃料排放,同时促进适应,为应对实际和未来的气候相关风险做好准备。儿科医生、家庭医生、流行病学家等卫生工作者可以倡导过渡,并支持公民和青年参与与气候有关的决策。
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引用次数: 0
[Climactions project: good practices of climate change adaptation and mitigation in 6 Italian cities]. [气候项目:意大利6个城市适应和减缓气候变化的良好做法]。
IF 1.5 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-03-01 DOI: 10.19191/EP25.2-3.S1.030
Paola Michelozzi
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引用次数: 0
[New European Pharmaceutical Legislation: a challenge to reconcile public health protection and market competitiveness]. [新的欧洲药品立法:协调公共健康保护和市场竞争力的挑战]。
IF 1.2 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2025-03-01 DOI: 10.19191/EP25.2-3.A802.026
Emanuele Sbraga, Chiara Gerardi, Eleonora Allocati, Rita Banzi, Silvio Garattini

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.

背景:在欧盟(EU)药品立法最后一次审查20年后,制药部门发生了重大变化,变得更加全球化。医疗需求得不到满足和获得创新治疗的机会不平等现象依然存在。此外,人们日益认识到开发新的抗生素和合理使用现有抗生素的必要性。在此背景下,欧盟委员会于2020年为欧洲提出了一项新的制药战略,旨在确保公平获得有效和安全的药物,同时加强该部门的全球竞争力。根据这一战略,委员会本身在2023年提出了对药品立法的全面改革,后来由欧洲议会进行了修订。目标:分析修改现行监管框架的一些主要建议,并讨论其对欧洲制药政策和公共卫生的影响。设计:分析当前药品监管环境,并与欧盟委员会和议会的主要提案进行比较。结果:最重要的改革建议有:1。数据和市场保护的变化,通过建立激励制度来支持创新,促进安全有效药物的开发和患者的使用,并使欧盟对制药公司具有吸引力;2. 鼓励开发新的抗微生物药物和控制抗微生物药物耐药性的一整套措施;3. 旨在提高欧洲药品管理局透明度的措施。结论:对当前药品立法改革草案的批判性和独立分析显示了可能深刻改变当前欧洲制药部门监管框架的重要新颖性,突出了一些关于某些建议的重要性和有效性的关键问题。一旦完成整个立法程序,就有可能看到改革的最后版本的执行,这将需要对其实际影响进行评估。
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Epidemiologia & Prevenzione
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