Management of links of interest in European Union expertise authorities dealing with plant protection products: comparative analysis and recommendations

IF 5.9 3区 环境科学与生态学 Q1 Environmental Science Environmental Sciences Europe Pub Date : 2023-11-08 DOI:10.1186/s12302-023-00760-1
Guillaume Karr, Giovanni Prete, Soraya Duboc, Denis Zmirou-Navier
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Abstract

Background

To ensure a high level of public health and environmental protection, authorities that deliver scientific expertise to inform decision-makers and the public at large need to be independent from external stakeholders and free of conflicts of interest. This independence requires effective rules for managing links of interest (LoIs) and a high level of transparency, including publication of declarations of interest (DoIs) where appropriate. In the particular case of plant protection products (PPPs) within the European Union, these requirements should apply to all Competent Authorities contributing to the marketing authorization processes.

Methods

A comparative analysis of LoIs management procedures was performed on a selection of ten National Competent Authorities from different member states (NCAs). This analysis was based on (i) the identification of 17 criteria aiming at characterizing good practices for LoIs management; (ii) a survey of ten NCAs, based on an analysis of their institutional websites and their responses to official mail requests.

Results

The comparative analysis showed: (i) a frequent lack of transparency of NCAs regarding their procedures for managing LoIs; (ii) a significant heterogeneity between the NCAs’ LoIs management rules, even though they are in charge of comparable missions regarding the marketing of PPPs; (iii) substantial gaps between the LoIs management procedures adopted by several NCAs and the good practices that are promoted by EFSA.

Current limits on their practices regarding LoIs management might open ways for undue external influences on scientific expertise, and ultimately impact negatively the risk management options adopted by national or European authorities. Limitations of this study and its extension for a more thorough overview of the current LoIs management practices are also discussed.

Conclusions

LoIs management and transparency rules need to be improved across NCAs, given their contribution as (co-)rapporteurs or peer reviews participants to the health and environmental risk assessment steps of the EFSA processes. To this end, a common minimum set of rules should be defined by EFSA; recommendations are proposed, based on the best practices implemented by the investigated NCAs. Such progress would contribute promoting high-quality unbiased scientific expertise and enhance EU citizens’ trust.

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管理与植物保护产品有关的欧洲联盟专门知识当局的联系:比较分析和建议
背景:为确保高水平的公共卫生和环境保护,提供科学专门知识为决策者和广大公众提供信息的当局需要独立于外部利益攸关方,不存在利益冲突。这种独立性需要有效的规则来管理利益联系(LoIs)和高度透明度,包括在适当情况下公布利益声明(DoIs)。在欧盟内植物保护产品的特殊情况下,这些要求应适用于所有参与上市许可程序的主管部门。方法对来自不同成员国的10个国家主管部门的意向书管理程序进行比较分析。这一分析的基础是(i)确定了17项标准,这些标准旨在描述LoIs管理的良好做法;(ii)基于对10个NCAs机构网站及其对官方邮件请求的回应的分析,对其进行调查。结果对比分析表明:(1)国家医疗服务机构在LoIs管理程序方面经常缺乏透明度;(ii)尽管它们负责ppp营销方面的类似任务,但它们的LoIs管理规则之间存在显著差异;(iii)几个国家认可机构采用的许可意见管理程序与欧洲食品安全局提倡的良好做法之间存在重大差距。目前对它们在意外书管理方面的做法的限制可能为外部对科学专门知识的不当影响开辟道路,并最终对国家或欧洲当局采取的风险管理备选办法产生不利影响。本文还讨论了本研究的局限性及其扩展,以便更全面地概述当前的LoIs管理实践。鉴于国家认可机构作为(共同)报告员或同行评审参与者对欧洲食品安全局流程的健康和环境风险评估步骤的贡献,需要改进其管理和透明度规则。为此,欧洲食品安全局应制定一套共同的最低限度规则;根据被调查的NCAs实施的最佳做法提出建议。这种进步将有助于促进高质量、公正的科学专业知识,并增强欧盟公民的信任。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Environmental Sciences Europe
Environmental Sciences Europe Environmental Science-Pollution
CiteScore
9.20
自引率
1.70%
发文量
110
审稿时长
13 weeks
期刊介绍: ESEU is an international journal, focusing primarily on Europe, with a broad scope covering all aspects of environmental sciences, including the main topic regulation. ESEU will discuss the entanglement between environmental sciences and regulation because, in recent years, there have been misunderstandings and even disagreement between stakeholders in these two areas. ESEU will help to improve the comprehension of issues between environmental sciences and regulation. ESEU will be an outlet from the German-speaking (DACH) countries to Europe and an inlet from Europe to the DACH countries regarding environmental sciences and regulation. Moreover, ESEU will facilitate the exchange of ideas and interaction between Europe and the DACH countries regarding environmental regulatory issues. Although Europe is at the center of ESEU, the journal will not exclude the rest of the world, because regulatory issues pertaining to environmental sciences can be fully seen only from a global perspective.
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