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European health data space
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 ...
Révision de la législation pharmaceutique de l’Union
Au cours de sa période de session plénière d’avril I, le Parlement européen est appelé à adopter sa position en première lecture sur deux propositions tendant à réviser la législation pharmaceutique de l’Union présentées par la Commission. Cette révision vise à renforcer la sécurité de l’approvisionnement en médicaments, à améliorer leur disponibilité et leur accessibilité et à les rendre plus abordables dans l’ensemble des pays de l’Union, tout en encourageant l’attractivité de l’industrie pharmaceutique ...
Protecting animals during transport
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 ...
Protection of workers: Limit values for lead and diisocyanates
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 ...
Medical Devices and In Vitro Medical Devices Regulations: Transitional provisions
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 ...
Revision of EU pharmaceutical legislation
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 ...
African Union–European Union cooperation on health
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
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 ...
Skyrocketing obesity in children: why everybody should be concerned?
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 ...
Certificats complémentaires de protection pour les médicaments
Au cours de sa période de session de février II, le Parlement devrait se prononcer en première lecture sur deux propositions législatives: une proposition de règlement de refonte concernant le certificat complémentaire de protection (CCP) et une proposition de règlement concernant le CCP unitaire, tous deux pour les médicaments. Ces propositions présentées en parallèle s’inscrivent dans un train de mesures plus large visant à renforcer les droits de propriété intellectuelle.