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.
A quiet week for formal legal changes. Several items below pre-date the window and are included because they are still pending; each carries its own date.
The AMNOG reform debate continues, while the GKV-BStabG pharma measures move toward their January 2027 start.
The G-BA's impartial chair criticised the Health Ministry's early-September proposals for a special assessment procedure for products with conditional approval, orphan status or accelerated assessment/PRIME. The proposals include accepting provisional patient-relevant endpoints and “best available evidence”, mandatory re-evaluation after 3–4 years and possible use of real-world data via the Forschungsdatenzentrum. The G-BA says the procedure would cover more than 60% of new approvals. The GKV-SV published its own statement on 18 September.
Why it matters: If adopted, evidence thresholds and re-assessment cycles for orphan and conditionally approved launches change — stress-test dossier and price-negotiation strategy now. These are proposals only; no draft bill has been published.
Sources: G-BA statement, 16 Sep 2026 (PDF) · GKV-SV statement, 18 Sep 2026 (PDF)
Passed by the Bundestag on 10 July 2026 and by the Bundesrat, published in the Federal Law Gazette on 29 July and largely in force from 30 July 2026. The manufacturer rebate rises from 7% to 15.5% and the vaccine discount to 9%, both from 1 January 2027; the price moratorium is extended to the end of 2030.
Why it matters: A direct hit on net-price planning for 2027 launches and existing portfolios. Check the exceptions (for example biosimilars) and the new rebate pilot for patent-protected products. Figures are from secondary summaries — verify against the Gazette text.
Sources: BMG press release, 10 Jul 2026 · Pharma Deutschland: law enters into force
A quiet week in Vienna.
We found no material new Austrian pharma or medical-device regulatory change with a verifiable date in this window.
Why it matters: Nothing to action for Austria specifically. The EU items below apply to Austria once in force, and EUDAMED obligations are covered in the next edition.
Sources: BASG — official announcements
Two Swiss deadlines to plan around: the swissdamed year-end close and the Therapeutic Products Act consultation.
Registration of devices, systems, procedure packs and IVDs in swissdamed became mandatory on 1 July 2026, with the transition period ending on 31 December 2026.
Why it matters: Importers and CH-REPs need complete registrations before year-end. Confirm scope and deadlines with Swissmedic.
Sources: PureGlobal, 31 Mar 2026
The Federal Council opened the consultation on the revision of the Therapeutic Products Act (HMG) on 19 June 2026; it runs to 16 October 2026. Proposals include simplified approval of medicines already authorised by comparable regulators, lifting the mail-order ban for non-prescription medicines, and a supervision fee on manufacturers and importers of medical devices.
Why it matters: A device supervision fee and simplified approvals would change Swiss cost and entry planning. Responses can still be filed until 16 October.
According to a law-firm report, the Council adopted the pharmaceutical reform on 28 September 2026. Reported content: 8 years of data protection plus 1–2 years of market exclusivity, orphan exclusivity of 9–11 years, a broader Bolar exemption, and EMA assessment cut from 210 to 180 days. Parliament approval and Official Journal publication are reported as pending; transposition runs two years after entry into force.
Why it matters: Changes to regulatory data protection and market-access conditionality affect lifecycle and launch sequencing across Germany and Austria. This rests on a single secondary source — confirm the adoption stage and dates on EUR-Lex.
Sources: Matheson: EU Council adopts new EU Pharma Package (30 Sep 2026) · Osborne Clarke, 31 Mar 2026
Following the Commission proposal of December 2025, a legal-blog report of 22 September 2026 expects Parliament's ENVI position by the end of 2026, trilogues concluding by the end of 2027 and entry into force in early 2028. Proposed changes include certificates of unlimited validity, sampling-based audits and a Class I baseline for software.
Why it matters: Plan certificate renewals and software classification on the current MDR until the revision is adopted. The timeline is an expectation, not a fixed schedule.
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 22–29 September 2026 and was issued on 29 September 2026.