European Union: Healthcare

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Article
A New Era For EU Pharma
The Council of the European Union has formally adopted the EU Pharma Package, marking the most significant revision of EU pharmaceutical legislation since 2004. This comprehensive reform introduces substantial changes to regulatory protection periods, innovation incentives, medicine shortage protocols, and market access mechanisms that will fundamentally reshape how pharmaceutical companies operate across the European Union.
European Union Healthcare
WF
William Fry
Article
EU Pharmaceutical Package: What The Council’s Revised Texts Mean For Companies
The Council has adopted its position on the EU Pharmaceutical Package at first reading, with legally and linguistically revised texts now available. While the main elements of the political compromise remain intact, several clarifications warrant attention as companies refine their implementation plans. This analysis identifies the most relevant changes in the Council's revised texts, assesses their practical significance, and outlines the next steps in the legislative process.
European Union Healthcare
CK
CMS Kluge Advokatfirma AS
Article
EU Council Adopts New EU Pharma Package
The Council of the EU has adopted the most comprehensive reform of EU pharmaceutical legislation in over 20 years, fundamentally reshaping regulatory protection mechanisms, market exclusivity periods, and incentive structures for pharmaceutical companies. These reforms balance patient access to medicines with creating a more competitive and innovation-friendly environment, addressing antimicrobial resistance, medicine supply challenges, and the early availability of generic alternatives.
Ireland Healthcare
M
Matheson
Article
The European Union Health Data Space: Unlocking The Value Of E- Health Data Through Responsible Governance
The European Union has spent the last decade reshaping the digital regulatory landscape through landmark legislation such as the General Data Protection Regulation (GDPR) and the AI Act. The European Health Data Space (EHDS) Regulation is the next significant step in that evolution. While often described as a healthcare initiative, the EHDS is at its core a data governance framework designed to unlock the value of electronic health data while safeguarding fundamental rights and promoting innovation.
Cyprus Healthcare
EN
Elias Neocleous & Co LLC
Article
Belgian Pharma Law Summer Blog Series (Part 1): The Act Of 30 May 2026 Containing Various Provisions On Medicinal And Health Products
Belgium introduces significant reforms to pharmaceutical law through the Act of 30 May 2026, addressing critical medicine shortages through enhanced export controls and stock allocation measures. The legislation also modernizes the Federal Agency for Medicines and Health Products' operational framework and adapts clinical trial regulations to support decentralized research models.
Belgium Healthcare
A
Altius
Article
Accès aux données de santé et intelligence artificielle : la Cour des comptes appelle indirectement à une simplification des procédures
La Cour des comptes examine les défis auxquels fait face la CNIL dans la gestion de l'accès aux données de santé, révélant des délais pouvant dépasser deux ans. Ce rapport soulève des questions cruciales sur la capacité des autorités françaises à soutenir le développement de l'intelligence artificielle en santé dans le contexte des nouveaux règlements européens AI Act et EEDS.
France Privacy
DA
Delsol Avocats
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