Europe: Food, Drugs, Healthcare, Life Sciences

The UK High Court has approved a groundbreaking dynamic blocking mechanism that allows pharmaceutical companies to block websites selling counterfeit medicines without requiring repeated court applications. This novel approach enables rights holders to self-certify breaches and directly instruct Internet Service Providers to block qualifying websites, marking a significant evolution in combating online pharmaceutical counterfeiting. The decision extends website blocking orders beyond traditional copyright e

The European Commission has published a comprehensive roadmap to phase out animal testing for chemical safety assessments by 2026, outlining 22 concrete actions across 15 legislative domains. While the communication itself is non-binding, it signals significant regulatory changes ahead that will reshape data requirements, testing strategies, and compliance obligations for businesses operating in pharmaceuticals, chemicals, and related sectors.

Turkey has introduced a comprehensive regulatory framework governing novel foods, establishing procedures for market authorization, scientific assessment, and data protection. The regulation defines novel foods, sets out application requirements, and introduces specific provisions for traditional foods from third countries while excluding pig- and insect-based products from authorization.

Bu çalışmada, sağlık meslek mensuplarına ve sağlık kurum ve kuruluşlarına yapılan değer aktarımlarının Türkiye’deki hukuki çerçevesi incelenmektedir. Sağlık sektöründe...

The European Commission has launched its first formal antitrust investigation in the medical devices sector, examining whether Align Technology may have abused its dominant position by restricting interoperability between its Invisalign clear aligners and competing intra-oral scanners. The investigation focuses on allegations that the company created a closed ecosystem, forcing dental professionals to purchase iTero scanners to access Invisalign products for their patients.

The OECD has released two groundbreaking test guidelines specifically designed for nanomaterials, addressing critical gaps in standardized testing methods for dustiness determination and environmental fate assessment. These new protocols provide regulatory frameworks for measuring how nano-objects behave under various conditions, supporting decision-making processes across OECD member countries. The guidelines build upon existing OECD testing standards while introducing specialized methodologies tailored to

Turkey's Ministry of Health has introduced significant amendments to the Personal Health Data Regulation, fundamentally changing how individuals can request re-evaluation of previously diagnosed medical conditions.

Bu çalışmada, sağlık meslek mensuplarına ve sağlık kurum ve kuruluşlarına yapılan değer aktarımlarının Türkiye’deki hukuki çerçevesi incelenmektedir. Sağlık sektöründe...

The European Commission has launched its first formal investigation in the medical devices sector, examining whether Align Technology's business practices constitute anticompetitive behavior by allegedly forcing dental professionals to purchase iTero scanners in order to use Invisalign clear aligners. The investigation centers on claims that Align has refused to approve competing scanners and rejected digital scans from other manufacturers since 2017, potentially creating a closed ecosystem that shields its