What does market access consulting cover when marketing authorisation, EU assessment and national reimbursement are decided in three separate procedures?
We guide pharma, biotech, medtech and IVD companies through the three procedures that decide market access: marketing authorisation, the joint clinical assessment at EU level under the HTA Regulation (EU) 2021/2282, and national reimbursement, which in Germany runs through the early benefit assessment under section 35a SGB V and the price negotiation under section 130b SGB V. What matters is not mastering each procedure separately but respecting their order: what was not built into the study design cannot be recovered at the negotiating table.
Overview
Three procedures decide market access, and only one of them is the marketing authorisation
Three procedures, one sequence · Sections 35a and 130b SGB V · EU 2021/2282 (EU HTA, JCA) · MDR and IVDR
Last updated: August 7, 2026
In Europe, market access is not one decision but a chain of three, each with its own standard, its own body and its own deadlines. Working through them one after another costs the window between authorisation and reimbursement. The levels at a glance:
- Marketing authorisation examines efficacy and safety before the regulatory authority. It says nothing about whether a payer will reimburse the product, which makes it not a market access milestone but its precondition.
- Since 12 January 2025 the clinical assessment has been consolidated EU-wide as a joint clinical assessment under (EU) 2021/2282 for new oncology medicines and ATMPs. Orphan medicinal products follow from 13 January 2028, the remaining centrally authorised medicines with new active substances from 13 January 2030.
- The reimbursement decision remains national. In Germany the G-BA assesses the added benefit against the appropriate comparator under section 35a SGB V, after which the reimbursement price is negotiated under section 130b SGB V. The JCA does not replace that assessment; it supplies its clinical basis.
- Medical devices and in vitro diagnostics follow a separate logic: CE marking under the MDR and IVDR permits placing on the market but governs no reimbursement. For high-risk products the Commission selects candidates for joint assessments individually rather than including them on fixed dates.
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What it comes down to
Market access is often described as a single step and is in fact a chain of three decisions. Marketing authorisation examines efficacy and safety. The clinical assessment has been consolidated EU-wide as a joint clinical assessment under (EU) 2021/2282 since 12 January 2025 for new oncology medicines and ATMPs, from 13 January 2028 for orphan medicinal products and from 13 January 2030 for the remaining centrally authorised medicines with new active substances. Reimbursement remains national: in Germany the G-BA determines the added benefit against the appropriate comparator under section 35a SGB V, after which the reimbursement price is negotiated under section 130b SGB V.
These three levels apply different standards, and that is precisely where programmes fail: a product tested against placebo can be authorised and still fail to demonstrate added benefit, because the G-BA requires comparison against established standard therapy. The order cannot be reversed. Comparator and patient-relevant endpoints have to be built into the study design long before the dossier falls due. Our work therefore starts in early development rather than at launch; the evidence roadmap is where those decisions are documented.
How much the field moves is visible this year: the guardrails introduced by the GKV Financial Stabilisation Act in section 130b(3) SGB V, which tied the negotiating room to the cost of the comparator therapy, were withdrawn with the GKV Contribution Rate Stabilisation Act with effect from 30 July 2026. Pricing models built on the earlier version are calculating against a rule that no longer applies. Medtech and IVD follow their own logic: CE marking under the MDR and IVDR permits placing on the market and governs no reimbursement. Where randomised trials are not sufficient, real-world evidence comes into play, with the limits that actually apply in the procedure.
Our approach
Our approach
Step
Result
Orientation
Clarity on which of the three levels applies to your product and when, which procedures run in parallel and where the hard deadlines sit.
Evidence planning
Agreed comparator, patient-relevant endpoints and data sources, fixed before the studies start rather than after they conclude.
EU and national submission
One shared EU evidence package for the joint clinical assessment and the national dossier, planned in parallel rather than in sequence.
Assessment and negotiation
A prepared benefit assessment under section 35a SGB V and a negotiation strategy for the reimbursement price under section 130b SGB V.
After launch
Monitoring of reimbursement status, reference prices and evidence gaps as the basis for renegotiation and portfolio decisions.
Common pitfalls
Where projects commonly fail
Market access is planned as a phase after authorisation.
By then the appropriate comparator and the patient-relevant endpoints are fixed and the studies are complete. The most common reason for a finding of 'added benefit not proven' arises years before the procedure, in the study design.
The joint clinical assessment is read as a replacement for the national assessment.
It is not: (EU) 2021/2282 consolidates the clinical assessment, not the reimbursement decision. Added benefit continues to be determined nationally, and both procedures must be served in parallel.
The legal position on the reimbursement price is assumed to be stable.
It is not: the guardrails introduced by the GKV Financial Stabilisation Act in section 130b(3) SGB V were withdrawn with effect from 30 July 2026. Anyone calculating with last year's pricing models is calculating against a rule that no longer applies.
For medtech and IVD, CE marking is equated with market access.
Conformity under the MDR or IVDR permits placing on the market; without a clarified reimbursement pathway and health economic evidence the result is a marketable but unreimbursed product.
The launch price is set without regard to reference markets.
Through external reference pricing an early or low negotiated amount carries into other markets, which makes the sequence of launches a pricing decision.
Market Access, RWE & Reimbursement
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- German Social Code Book Five (SGB V), section 35a (early benefit assessment / AMNOG) and section 130b (reimbursement price negotiation)
- Regulation (EU) 2021/2282 on health technology assessment (EU HTA, joint clinical assessment), dates of application under Art. 7 and the transitional provisions
- GKV Contribution Rate Stabilisation Act, published 29 July 2026 (BGBl. 2026 I No. 228), in force since 30 July 2026
- AM-NutzenV (German ordinance on medicinal product benefit assessment); Code of Procedure of the Federal Joint Committee (VerfO G-BA)
- Regulation (EU) 2017/745 (MDR); Regulation (EU) 2017/746 (IVDR)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- Section 35a SGB V (early benefit assessment / AMNOG)
- Section 130b SGB V (reimbursement price negotiation)
- AM-NutzenV (German ordinance on medicinal product benefit assessment)
- Code of Procedure of the Federal Joint Committee (VerfO G-BA)
- EU 2021/2282 (EU HTA Regulation, joint clinical assessment)
- EU 2017/745 (MDR)
- EU 2017/746 (IVDR)
Related topics
Market Access Strategy →
The evidence roadmap: fixing comparator and endpoints before studies start
Pricing & Reimbursement →
Price corridor, launch sequence and the reimbursement price under section 130b SGB V
HTA Dossier →
The benefit assessment dossier for the G-BA and IQWiG under section 35a SGB V
Value Dossier →
A value story that holds for authorisation, HTA and negotiation
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