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The COVID-19 pandemic highlighted the need for a resilient healthcare system but also for quick access to inventions and technologies in challenging situations. To address this need, in April 2023 the Commission submitted a proposal for a regulation on compulsory licensing for crisis management. The aim is to secure the rapid deployment of patent-protected inventions in times of crisis or emergency, without eroding patent protection as an incentive to innovate. The proposal lays down rules and procedures ...

Retail investor package

Briefing 22-04-2024

On 24 May 2023, the European Commission put forward a package of two proposals to amend existing directives and a regulation with a view to fostering retail investor information transparency and ensuring that investment decisions are best for investors. The objective is to enhance trust and confidence, thereby increasing retail investor participation in financing the economy. The package is mostly concerned with clarity in communication and the prevention of misleading marketing. It also seeks to ...

Air pollution is the single largest environmental health risk in the EU and causes significant damage to ecosystems. As part of the European Green Deal's zero pollution ambition, on 26 October 2022 the European Commission tabled a proposal for a revision of the Ambient Air Quality Directives. The proposed directive would set air quality standards for 2030 that are more closely aligned with World Health Organization (WHO) recommendations, as updated in 2021. It would also include a mechanism for the ...

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 ...

Revision of the Ozone Regulation

Briefing 16-04-2024

Stratospheric ozone absorbs ultraviolet radiation from the sun and reduces the overall amount of radiation reaching the Earth's surface. Ozone-depleting substances (ODS) are human-made chemicals that, once emitted, reach the upper atmosphere and destroy the protective ozone layer, causing what is known as the ozone hole. They have significant adverse impacts on human health and the environment and are also greenhouse gases with high global warming potential. Regulation (EC) No 1005/2009 on substances ...

On 1 March 2023, as part of the road safety package, the European Commission published a legislative proposal to help ensure EU-wide application of driving disqualifications. The proposal calls for increased cooperation, harmonisation of legislation, simplification of information exchange, capacity building, and improved public awareness efforts. In order to prevent impunity due to a lack of legislation, the proposal sets out rules to allow better EU-wide enforcement of driver disqualification decisions ...

In December 2022, the European Commission presented two proposals to revise the rules on the collection and transfer of advance passenger information (API) data – data collected by air carriers at check-in and sent to competent authorities in the country of destination prior to take-off. One of the proposals is for a new regulation on the collection and transfer of API data for the prevention, detection, investigation and prosecution of terrorist offences and serious crime. The proposal seeks to ...

In December 2021, the European Commission presented a proposal to amend the Schengen Borders Code, which lays down the rules governing controls at the EU internal and external borders. While debates on the reform of Schengen have been going on for a while, recent challenges – relating to the coronavirus pandemic on the one hand, and attempts to instrumentalise migrants as a way to put pressure on the EU's external borders, on the other – have created new momentum for reform. The Commission's proposal ...

Directive 2009/138/EC – also known as Solvency II – sets out the prudential regulatory framework for the insurance sector in the EU. The framework aims to establish the single market for insurance services further, while strengthening policyholders' protection. On 22 September 2021, the European Commission tabled a proposal for a directive that would amend Solvency II in essentially three ways: i) lowering regulatory obligations on small and low-risk profile insurance companies, ii) taking into account ...

In July 2023, the European Commission tabled a package of proposals aimed at greening freight transport. One of these proposals focuses on improving the use of rail infrastructure capacity. The proposed text suggests changes to the rules governing the planning and allocation of railway infrastructure capacity, which are currently outlined in Directive 2012/34/EU and Regulation (EU) No 913/2010. The goal of the changes is to enhance the management of rail infrastructure capacity and traffic as a way ...