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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 ...

Artificial intelligence act

Briefing 11-03-2024

European Union lawmakers reached a political agreement on the draft artificial intelligence (AI) act in December 2023. Proposed by the European Commission in April 2021, the draft AI act, the first binding worldwide horizontal regulation on AI, sets a common framework for the use and supply of AI systems in the EU. It offers a classification for AI systems with different requirements and obligations tailored on a 'risk-based approach'. Some AI systems presenting 'unacceptable' risks are prohibited ...

Strategic foresight was identified as a political priority by the European Commission back in 2019, and was integrated into the EU's better regulation guidelines in 2021. It allows practitioners to anticipate alternative futures and, hence, represents a key tool for the EU to future-proof its policies and legislation. Its relevance spans the policy cycle, being of interest ex ante to impact assessments (IAs) and ex post to evaluations. This briefing examines the use of strategic foresight by the ...

On 27 April 2023, the Commission submitted its proposal for a regulation on standard essential patents (SEPs). During its second February 2024 plenary session, Parliament is to vote on the report adopted by its Committee on Legal Affairs. This would set Parliament's position for trilogue negotiations with the Council on the proposal.

During the February II plenary session, the European Parliament is expected to adopt its first-reading positions on two legislative files – a proposed regulation on the unitary supplementary protection certificate for plant protection products and a proposed recast regulation on supplementary protection certificates for plant protection products. The proposals are part of a broader initiative to harmonise patent protection within the single market.

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 ...

In February, Parliament will vote on the report adopted by its Committee on the Environment, Public Health and Food Safety (ENVI) on a proposal regulating plants obtained by certain new genomic techniques. The text as voted will form Parliament's position for negotiations with the Council, which has still to agree on its position.

The International Commission for the Conservation of Atlantic Tunas (ICCAT) is an intergovernmental fisheries management organisation responsible for tuna and tuna-like fish stocks in the Atlantic Ocean. During the February I plenary session, the European Parliament is due to vote on an agreement with the Council of the EU to transpose a number of binding ICCAT measures into EU law.

The path to 6G

Briefing 30-01-2024

The European Union needs high-performing digital connectivity infrastructure to give all citizens the best access to digital services and to maintain prosperity. In the relentless pursuit of innovation and connectivity, the development of mobile communications technologies has been a defining force in shaping the way we communicate, work, and live. As the 2030s approach, the groundwork for the next frontier in mobile communications is being laid – the era of 6G. Building upon the successes and advances ...

As Russia’s brutal and unprovoked war on Ukraine approaches the two-year mark in February, the front lines have remained virtually static for several months. On 17 January, at the World Economic Forum in Davos, President Volodymyr Zelenskyy urged Ukraine and its people to seize the initiative to help determine the course of the war and secure more extensive international support. Earlier, Zelenskyy expressed confidence that the key aid from Washington, delayed by infighting in the US Congress, would ...