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The proposed revision of the EU's pharmaceutical framework covers the EU's general pharmaceutical legislation and the paediatric and orphan medicines regulations ('specific pharmaceutical legislation') in an integrated manner. The merger of the orphan and paediatric regulations with the legislation applicable to all medicinal products is explained with 'simplification and increased coherence' in the explanatory memorandum of the proposed directive. The proposed revision is supported by two impact ...

The IA supports the revision of the EU customs legislation to ensure an integrated approach to reinforcing the customs processes, data management and governance framework. It considers four policy options (POs), each with an increasing degree of ambition and a concrete implementation timeline. The four POs are complimentary, rather than separate alternatives, and appear realistic and self-standing. The IA assesses the impacts of all POs both quantitatively and qualitatively, and selects PO4 – 'EU ...

The impact assessment is based on extensive internal and external expertise, including several studies, tailored EBA advice and JRC input. In line with the 'evaluate first' principle, it builds on an evaluation and develops a consistent intervention logic. The options presented to address the problems identified are packages of legislative amendments, with increasing ambition to enhance application of the EU resolution framework and facilitate the decisions on the appropriate resolution tools. The ...

In line with the overall objectives of the European Green Deal, the proposed initiative aims to render consumption more sustainable by increasing the repair and reuse of defective consumer goods, both within and outside their legal guarantee. It complements two related initiatives that are currently pending (eco-design and empowering consumers for the green transition). The IA presents a clear intervention logic and a seemingly comprehensive qualitative and quantitative assessment of the impacts ...

The initiative's objective is to facilitate the use of digital tools and processes in EU company law. The problem definition appears to be well supported by evidence. The IA substantiates the nature and scale of the problem, as well as who it affects (business registers, public authorities, businesses, citizens/ consumers) and how. The policy options are not alternatives to each other but each one of them is a group of (sub-) options for each of the four intervention areas. The sub-options under ...

This briefing provides an initial analysis of the strengths and weaknesses of the European Commission's impact assessment (IA) accompanying the above-mentioned proposals, submitted on 7 December 2022 and referred to the European Parliament's Committee on Economic and Monetary Affairs (ECON). The initiative – which would modify the existing framework applying to EU central counterparties (CCPs) and market participants using their services – aims to reduce the over reliance of EU financial markets ...

This IA supports the proposal for a revision of the 2011 Directive on preventing and combating trafficking in human beings and protecting its victims. Overall, it provides a complete and detailed explanation of the problem, of its scope, drivers, and of the need to take EU-level action. It is well-substantiated and relies on the evaluation of the directive conducted in parallel with the IA, stakeholder feedback, comprehensive desk research and recent data from Eurostat. The IA is also transparent ...

The IA examines the nature and scale of the problems sufficiently (the fact that not every person crossing the Schengen external borders is pre-checked with API data and that there are security gaps in the processing of air passenger data for law enforcement purposes). The IA provides a comprehensive description of the options. The sub-options under each of the intervention areas identified are limited and mostly cumulative; the range of alternative options therefore appears limited. The assessment ...

The IA is underpinned by solid internal and external expertise and based on integrated modelling coherent with the interlinked European Green Deal and the REPowerEU initiatives. It is transparent on methods, builds on specifically updated assumptions and addresses potential uncertainties with two sensitivity analyses. Despite slight weaknesses in the definition of the problems and objectives, the intervention logic of the initiative is clear. The IA's annexes contain a lot of relevant information ...

The IA is convincing on the need to expand sustainable carbon removals and encourage innovative solutions to capture, recycle and store CO2. It points to the transboundary nature of climate change as justifying EU action, but the proportionality of the initiative is not discussed and there is no subsidiarity grid to further clarify the proposal's subsidiarity and proportionality aspects. The IA identifies three problems hindering effective and sustainable carbon removal activities; it describes them ...