Health ministry · Research and innovation

Health innovation: how a discovery becomes a treatment

Between a laboratory result and a patient’s bedside lie trials, approvals, benefit assessments and price negotiations. Germany has spent recent years shortening that path. The question now is whether faster also means better — and affordable.

The innovation pipeline from research to care Six stacked stages narrowing like a funnel: research, clinical trials, authorisation, benefit assessment, reimbursement and care. Beside each stage the German or EU instrument: research centres and the Hightech Agenda; the Medical Research Act; EMA, BfArM and the Medical Device Regulation; G-BA and AMNOG; statutory health insurance; and the electronic patient record. A return arrow labelled real-world data runs from care back to research. RESEARCH centres · Hightech Agenda TRIALS Medical Research Act 2024 APPROVAL EMA · BfArM · MDR BENEFIT G-BA · AMNOG PRICE GKV negotiation CARE patients real-world data · ePA · FDZ Each stage narrows: most candidates never reach patients.

01 / Why it matters

Patients first, industry second — but both

Health innovation has two audiences. For patients it determines which diagnoses become possible and which treatments become available, and when. For the economy it is an industry: pharmaceuticals, medical technology, biotechnology and digital health employ highly qualified people and export worldwide. The two goals usually point the same way — research and production close to the health system make early access easier — but not always: a policy that attracts investment by keeping prices high also raises costs for contribution payers.

This page focuses on the health side and links out to growth and competitiveness for the economic debate. Carsten Linnemann brings an economist’s background to the ministry and, until June 2026, served on the board of trustees of the Fraunhofer Institute for Mechatronic Systems Design in Paderborn. In the Health Committee on 23 September 2026 he set the aim of making Germany’s health system the most capable in the world (hib 733/2026). He has not, so far, announced a specific innovation programme; the instruments described here are inherited.

Responsibilities are split. The Federal Ministry of Health covers approval law, clinical trials, benefit assessment and reimbursement. The Federal Ministry of Research, Technology and Space (BMFTR) funds research programmes and, jointly with the Länder, the German Centres for Health Research. The Länder fund universities and university hospitals. The EU sets the rules for authorising medicines and certifying medical devices and AI.

  • Inherited
  • Under review
  • Proposed
  • In implementation
  • In force
Medical Research Act
In force 30 Oct 2024
Hightech Agenda
Cabinet 31 Jul 2025; ≈€18bn to 2029 (BMFTR)
Genome sequencing pilot
Started Jul 2024; at least five years
EU AI Act
In force 1 Aug 2024; staged obligations
Research data centre
Opened 9 Oct 2025 at BfArM
02 / Fields

Six fields of health innovation

Each with its promise, its regulatory gate and its current status in German policy.

01

Medicines and biotech

In force · inherited

New active ingredients, cell and gene therapies and biologics pass EU authorisation and then the German AMNOG benefit assessment. The Medical Research Act aims to speed up trials; the Hightech Agenda names biotechnology as one of six key technologies. See pharmaceutical policy.

02

Medical technology

In force · EU

Devices from implants to imaging systems are certified under the EU Medical Device Regulation, applicable since May 2021. Manufacturers, many of them medium-sized firms, have reported long and costly certification procedures.

03

Diagnostics

In implementation

Laboratory and imaging diagnostics enter statutory insurance through G-BA decisions. Companion diagnostics that identify who benefits from a targeted therapy link diagnostics directly to medicines.

04

Precision medicine

In implementation · inherited

The model project on genome sequencing under § 64e SGB V started in July 2024 for people with rare diseases and cancers, for at least five years, coordinated within the national genomDE strategy.

05

Artificial intelligence

Open question

AI for medical purposes must meet both medical-device rules and the EU AI Act. The Hightech Agenda aims to accelerate the use of AI in medicine; the health ministry has not set out its own AI strategy since July 2026.

06

Digital applications

Inherited

Apps on prescription (DiGA) and telemedicine have a reimbursement route that few countries offer. Their evidence base and pricing remain contested. See digital health.

07

Data for research

In implementation

The research data centre at the BfArM and the pending Medical Registers Act make routine-care data available for research under strict conditions. See health data.

08

Research infrastructure

Ongoing

The German Centres for Health Research and the Medical Informatics Initiative at university hospitals are long-term federal research programmes, funded through the research ministry.

03 / The Medical Research Act

Faster trials, faster approvals

The Medizinforschungsgesetz (MFG) is the main inherited instrument for research-based industry. Cabinet 27 March 2024, Bundestag 4 July 2024, Bundesrat 27 September 2024, in force 30 October 2024.

  1. Simpler trial approval

    Procedures for clinical trials of medicines and medical devices, and for research involving radiation, were streamlined and deadlines shortened. In force

  2. Federal ethics committee

    A specialised federal ethics committee at the BfArM was planned to take on complex first-in-human, gene and cell therapy trials. In implementation

  3. Standard contract clauses

    More binding model clauses for trial contracts between sponsors and hospitals, to cut weeks of negotiation. In implementation

  4. Confidential prices

    Companies with relevant research in Germany may keep negotiated reimbursement prices confidential — limited until the end of June 2028, with an evaluation planned by the end of 2026. Evaluation due

Supporters and critics

Supporters — research-based manufacturers, many university hospitals and patient groups for rare diseases — argue that Germany had fallen behind in the number of clinical trials and that faster procedures bring earlier access to new treatments for patients in Germany.

Critics focused on confidential prices. Statutory insurers, several medical associations and pharmacists warned that hidden prices could raise costs and complicate prescribing decisions, because doctors and pharmacies could no longer see the reimbursed amount. The Bundestag responded by limiting the rule in time and tying it to research activity in Germany.

The evaluation due by the end of 2026 falls into Linnemann’s tenure. Whether he extends, amends or ends the confidential-price option will be one of the first innovation decisions that is genuinely his. Open question

04 / Funding

Who pays for health research?

≈€18bnPlanned investment under the Hightech Agenda Deutschland through 2029, across six key technologies including biotechnology and AI2025–2029 · BMFTR via Forschung & Lehre
6Key technologies of the Hightech Agenda: AI, quantum, microelectronics, biotechnology, climate-neutral energy and mobilityCabinet decision 31 Jul 2025

Public research funding for health flows through several channels. The federal research ministry funds programmes and the German Centres for Health Research, which pool university and non-university institutes around major disease areas, together with the Länder. The Hightech Agenda Deutschland, adopted by the cabinet on 31 July 2025 under research minister Dorothee Bär, prioritises six key technologies, among them biotechnology and AI, and names health research as a strategic field; one of its stated aims is to accelerate the use of AI in medicine. In implementation · BMFTR

The statutory health insurers also fund innovation directly. The model project on genome sequencing is financed by the insurers, and the Innovation Fund at the Federal Joint Committee supports new forms of care and health-services research. The research data centre at the BfArM, opened in October 2025, adds data rather than money.

Universities and university hospitals — where much clinical research happens — are funded by the Länder. Their investment backlog, and the financial pressure on hospitals described on the hospitals page, limit research capacity in clinical settings.

For the health ministry, the key innovation lever is not research funding but the rules of access: how quickly a new product can be tested, approved, assessed and paid for. That is where the MFG, the AMNOG and the digital laws matter.

05 / Early access

From EU approval to German prescription

Germany is unusual in Europe: a new medicine can be prescribed and reimbursed as soon as it is authorised and launched, before its added benefit has been assessed.

Authorisation

Most new medicines are authorised centrally for the whole EU on the recommendation of the European Medicines Agency.

Launch

The manufacturer can launch in Germany immediately; statutory insurance pays the manufacturer’s price during the first months.

Dossier

At launch the manufacturer submits a dossier on added benefit compared with the appropriate standard therapy.

Assessment

The G-BA decides on the added benefit, usually after an IQWiG assessment, within about six months.

Negotiation

The GKV-Spitzenverband and the manufacturer agree a reimbursement price that applies from the seventh month; an arbitration board decides if they cannot agree. Since 2022 the period of free pricing is six months instead of twelve.

Use in care

Real-world data — increasingly from registers and the research data centre — can inform later reassessment.

This model gives patients in Germany early access compared with many European countries, where reimbursement decisions can take longer. It also makes Germany a reference market: other countries look at German prices, which is one reason why manufacturers valued the confidential-price option introduced in 2024. The arrangement is In force · inherited; no change has been announced since July 2026. Any future reform that touches the early-access period, the evidence required at launch or the confidentiality of prices would directly affect both the affordability and the innovation goals described on the pharmaceutical-policy page.

06 / Debate

Can Germany afford its own innovation?

The tension between early access and financial sustainability, as it is argued in the German debate.

Argument for an innovation-friendly course

  • Early access to new medicines and devices is a strength of the German system for patients.
  • Research and production in Germany reduce dependence on other regions — a lesson of the supply shortages.
  • Clinical trials give patients access to treatment before approval and keep expertise in hospitals.
  • Data infrastructure and genome medicine can make treatment more targeted and avoid ineffective therapy.

Concerns and counter-arguments

  • High launch prices for new therapies raise contribution rates that Linnemann wants to stabilise.
  • Faster approval can mean less evidence at launch; benefit must still be shown.
  • Industrial-policy goals should not be financed through health-insurance contributions.
  • Not every innovation improves outcomes; some add cost without added benefit.

The government’s answer so far combines faster procedures (MFG) with tighter cost control (a higher manufacturer discount from 2027). Whether both can be pursued at once without discouraging investment is the open question of Linnemann’s term.