Q3 2026 brought a number of important legal and regulatory developments for the life sciences sector. The Q3 2026 edition of BAHR’s Life Sciences Quarterly gathers the key developments we’ve been tracking in Norway and the EU over the past quarter, including:
- Greater transparency in Norwegian market access, as Nye Metoder begins publishing rationales for decisions adopted by the Decision Forum, providing greater insight into the assessments underlying reimbursement and funding decisions.
- Norway’s proposed implementation of the EU’s SoHO Regulation, which would establish a significantly broader regulatory framework for substances of human origin and bring activities such as platelet-rich plasma (PRP), faecal microbiota transplantation (FMT), donor breast milk and certain adipose-derived cell therapies within a harmonised regulatory framework.
- Major EU legislative developments, including the Council of the European Union’s adoption of the EU Pharma Package, marking a significant milestone in the reform of the EU pharmaceutical framework.
- Key EU regulatory and case law developments, including EFPIA’s response to the EU Biotech Act consultation, MedTech Europe’s comments on the classification of high-risk AI systems, and the CJEU’s judgment in C-427/24 Diagramm Halbach, which provides important guidance on the role of promotional claims in the assessment of whether a product qualifies as a medical device under the MDR.
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