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European health data space

Briefing 18-04-2024

The COVID-19 pandemic shone a light on the growing importance of digital health technologies, both to enable remote medical care and to facilitate the health response from international, national and local authorities. The European Commission's May 2022 proposal for a regulation on a European health data space aims to improve individuals' access to and control over their electronic personal data (primary use), while facilitating data re-use for the good of society across the EU (secondary use). The ...

In October 2022, under the European Green Deal, the European Commission tabled a proposal for a recast of the Urban Wastewater Treatment Directive. Dating back to 1991, and instrumental to the achievement of European Union water policy objectives, the directive needs to be updated and adapted to new challenges and realities. The recast proposal would introduce new obligations to do more to control pollution due to rainwater, impose stricter standards for nutrient removal and require advanced treatment ...

On 26 April 2023, the European Commission put forward a 'pharmaceutical package' to revise the EU's pharmaceutical legislation and make medicines more available, accessible and affordable, while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards. The package includes proposals for a new directive and a new regulation, which would replace the existing pharmaceutical legislation, including the legislation on medicines for children ...

In December 2022, the European Commission proposed a revision of the Regulation on the classification, labelling and packaging of substances and mixtures, one of the two cornerstones of the EU's framework regulating chemicals. The revision, announced in the EU chemicals strategy for sustainability, notably seeks to identify and classify hazardous chemicals more comprehensively; improve communication on chemical hazards and the notification of relevant information to poison centres for emergency health ...

On 17 November 2021, the European Commission tabled a proposal to revise EU rules on shipments of waste. The proposed regulation seeks to ease shipments of waste for reuse and recycling in the EU, to support the transition to a circular economy; ensure that waste exported from the EU is managed in an environmentally sound manner in the destination countries; and step up enforcement to counteract illegal shipments of waste. While supporting the proposed streamlining and digitalisation of procedures ...

As announced in the EU biodiversity strategy for 2030, on 22 June 2022 the European Commission tabled a proposal for a nature restoration regulation. The proposed regulation would set multiple binding restoration targets and obligations across a broad range of ecosystems, from forests and agricultural land to urban areas, rivers and marine habitats, complementing other existing legal instruments. Altogether, these nature restoration measures should cover at least 20 % of the EU's land and sea areas ...

A febbraio il Parlamento voterà sulla relazione approvata dalla commissione per l'ambiente, la sanità pubblica e la sicurezza alimentare (ENVI) riguardante una proposta di regolamento relativo alle piante ottenute mediante alcune nuove tecniche genomiche. Una volta approvata in Aula, la relazione costituirà la posizione del Parlamento in vista dei negoziati con il Consiglio, il quale non ha ancora concordato una posizione.

La salute è un diritto umano fondamentale e il conseguimento della parità di accesso ai medicinali è essenziale per garantire la salute pubblica. L'attuale sistema di innovazione farmaceutica dipende in larga misura dal settore privato e la remunerazione dell'innovazione si fonda principalmente sulle esclusive. Tale sistema comporta svariate sfide, come ad esempio il fatto che l'innovazione è guidata dalla dimensione del mercato, il parziale disallineamento fra le priorità di ricerca e sviluppo dell'industria ...

Under the farm to fork strategy, part of the European Green Deal, the EU has set itself a double target: a 50 % reduction in the overall use of and risk from chemical plant protection products, and a 50 % reduction in the use of more hazardous ones by 2030. The proposal for a regulation tabled by the European Commission on 22 June 2022, which would replace the 2009 sustainable use directive, would require Member States to contribute collectively to achieving these EU-wide targets through the adoption ...

Ad aprile 2023 la Commissione ha adottato alcune proposte di regolamento che introducono un certificato protettivo complementare (CPC) unitario e una procedura di valutazione centralizzata per i CPC dei medicinali. Il presente studio analizza le potenziali ripercussioni di tali proposte sull'accesso ai medicinali, gli oneri amministrativi a carico dei richiedenti e i costi per i sistemi sanitari nazionali. Questo documento è stato elaborato dal Dipartimento tematico Diritti dei cittadini e affari ...