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Überarbeitung des EU-Arzneimittelrechts

Auf einen Blick 08-04-2024

Auf der April-I-Plenartagung nimmt das Europäische Parlament voraussichtlich seinen Standpunkt in erster Lesung zu zwei Vorschlägen der Kommission zur Überarbeitung des EU-Arzneimittelrechts an. Durch die Überarbeitung soll die Versorgungssicherheit bei Arzneimitteln verbessert werden, indem Arzneimittel in allen Ländern der EU besser verfügbar, zugänglicher und erschwinglicher gemacht werden und gleichzeitig die Attraktivität der pharmazeutischen Industrie in der EU durch die Förderung von Forschung ...

The impact assessment (IA) defines the problems, their drivers, the objectives and the options of the initiative in a robust intervention logic. It is based on several sources, including the 'fitness check' of current EU animal welfare legislation, an external supporting study and stakeholder feedback. The IA presents a range of policy options; however, for some options, it does not provide alternatives. The assessment of the options' impacts (economic, social, environmental, animal welfare) is qualitative ...

As part of its fight against harmful substances, on 13 February 2023 the European Commission tabled a proposal for a directive aimed at protecting workers' health by lowering occupational exposure to lead and diisocyanates. In Parliament, the Committee on Employment and Social Affairs, which is responsible for the file, adopted its report on 7 September 2023. The mandate to enter into interinstitutional negotiations was endorsed by the plenary the following week. On 14 November 2023, Parliament and ...

On 23 January 2024, the European Commission put forward a proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746, to give manufacturers time to apply the EU legislation on, respectively, medical devices and in vitro diagnostic medical devices (IVDs) under certain conditions, without compromising safety requirements. IVDs are non-invasive tests used on biological samples (such as blood, urine or tissues) to determine the status of a person's health. A considerable number of ...

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 line with its 2022 global health strategy (GHS), the expansion of international partnerships on health is a priority for the European Union (EU). As the 2020 Africa strategy underlines, the African continent, including at regional and national levels, is one of the EU's strategic partners, not least on health. Nevertheless, it was not until February 2022, in the wake of the COVID-19 pandemic, that health was explicitly included as one of the strategic priorities of the EU–African Union (AU) partnership ...

Future-proofing the EU's global health strategy

Eingehende Analyse 13-03-2024

The new EU global health strategy, adopted by the European Commission on 30 November 2022, has been positioned as a crucial element of EU external policy, geopolitical influence and strategic autonomy. However, maintaining the long term commitment necessary for achieving global health ambitions in turbulent times remains challenging. Against this backdrop, in 2023 the Policy Foresight Unit of the European Parliamentary Research Service conducted a foresight exercise involving external experts to ...

Nearly 400 million children around the world are projected to live with obesity by 2035. Worryingly, that is double the number in 2020. 'Our children are increasingly growing up in environments that make it very difficult for them to eat well and be active. This is a root cause of the obesity epidemic', argued Dr Hans Henri P. Kluge, Regional Director for the World Health Organization (WHO) in Europe. Worryingly, child obesity often carries through to adolescence and is likely to endure into adulthood ...

Auf seiner Februar-II-Tagung wird das Europäische Parlament voraussichtlich über seinen Standpunkt in erster Lesung zu zwei Legislativvorschlägen abstimmen. Dabei handelt es sich um einen Entwurf zur Neufassung der Verordnung über das ergänzende Schutzzertifikat (ESZ) und einen Entwurf einer Verordnung über das einheitliche ergänzende Schutzzertifikat, die beide Arzneimittel betreffen. Diese parallelen Vorschläge sind Teil eines umfassenderen Pakets zur Verbesserung der Rechte des geistigen Eigentums ...

Im Februar 2023 legte die Kommission einen Vorschlag für eine Richtlinie vor, mit der die bestehenden Grenzwerte für Blei überarbeitet und erstmals Grenzwerte für Diisocyanate eingeführt werden sollen, um ein hohes Schutzniveau für die Gesundheit und Sicherheit der Arbeitnehmer zu erreichen. Am 14. November 2023 gelangten die gesetzgebenden Organe zu einer vorläufigen Einigung über den Vorschlag. Über den vereinbarten Text, der noch von beiden Organen förmlich angenommen werden muss, wird voraussichtlich ...