Market-access intelligence for life sciences — a weekly scan of DE, AT and CH regulatory changes, with what each means for pricing, reimbursement and getting paid.
No new binding Austrian rule in this window. Germany and the EU carry the week; Switzerland adds two dated items.
Medical-aid tenders pass the Bundestag; screening demand for imaging grows.
The Bundestag adopted the emergency-care reform. As a carrier law it reintroduces tenders for Hilfsmittel by statutory health insurers; tenders for compounded cytostatics were dropped beforehand. It also sets up integrated emergency centres (INZ) and a limited dispensing right for doctors. The Bundesrat must still consent.
Why it matters: Hilfsmittel makers and their homecare partners should model tender pricing and decide whether to bid directly or through partners. Timing depends on Bundesrat consent and implementation by the insurers.
Sources: PZ, 15 Oct 2026
The G-BA extended the national mammography screening programme to women aged 45–49 (about 2.5 million more eligible). If the Health Ministry does not object, the change takes effect on 1 August 2027; self-registration is expected from then and personal invitations from about January 2028.
Why it matters: More screening volume for imaging, biopsy and AI-reading vendors serving German screening units — procurement and capacity planning should start in 2027.
Sources: G-BA press release, 15 Oct 2026
Quiet for market access; one EU deadline to keep in view.
The six-month transition after Commission Decision (EU) 2025/2371 ends around the end of November 2026, according to our reading of the BASG notice.
Why it matters: Austrian operators: complete EUDAMED actor and UDI/device registration now. Confirm the exact date with BASG.
Sources: BASG notice
New pharmacopoeia date and a 3R strategy; the HMG consultation has closed.
Swissmedic's Institute Council decided that the 13th edition of the Swiss Pharmacopoeia will enter into force on 1 April 2027.
Why it matters: Manufacturers and importers supplying Switzerland should check monographs and specifications against Ph. Helv. 13 before April 2027.
Sources: Swissmedic, 16 Oct 2026
Swissmedic announced a new strategic approach to minimising animal testing in the development of medicinal products for human use.
Why it matters: Developers planning Swiss filings may be able to rely more on non-animal methods; watch for concrete guidance.
Sources: Swissmedic, 19 Oct 2026
The consultation on the HMG revision, including a supervision fee for medical-device manufacturers and importers, ended on 16 October 2026.
Why it matters: Watch for the consultation report and dispatch to Parliament; the fee design will affect device makers and importers.
The EMA recommended EU approval of Lilly's orforglipron, an oral non-peptide GLP-1 receptor agonist, for weight management (BMI ≥30, or 27–30 with a comorbidity) and type 2 diabetes. The Commission decision follows.
Why it matters: In Germany, weight-loss drugs are largely excluded from statutory coverage as lifestyle drugs, while the diabetes indication goes through AMNOG. Expect a closely watched pricing and reimbursement split.
Sources: PZ, 16 Oct 2026
No plenary date confirmed yet; November remains the indicative month.
Why it matters: No change to plans; keep the gap analysis running.
We advise life-sciences companies on pricing, reimbursement and regulatory strategy across Germany, Austria and Switzerland. Book a call to work through what these changes mean for your portfolio.
Book a session →Disclaimer. This digest is prepared by BCA (bcaun.de) for general information only and is not legal advice. Regulatory positions change quickly: every item marked Transition, Watch or In ratification is not settled law, and dates, scope and entry-into-force can shift. Confirm any such item directly with the competent regulator — BfArM, PEI, G-BA or GKV-Spitzenverband in Germany; BASG/AGES in Austria; Swissmedic in Switzerland; the European Commission or EMA at EU level — before acting. This edition covers 14–20 October 2026 and was issued on 20 October 2026.