Germany has kicked off a new Pharma and MedTech Dialogue that aims to develop new policies and regulatory reform proposals to re‑establish Germany as a competitive, innovation‑friendly location for life sciences R&D and manufacturing. The outcome of this dialogue shall be the basis for a new German Pharma and MedTech Strategy.
I. The Pharma & MedTech Dialogue – A Familiar Format
A “Pharma Dialogue” has existed in various iterations since 2014, traditionally serving as a high-level stakeholder forum involving the German Government and stakeholders from the life sciences industry, health insurances, patient representatives and other groups.
The current German Government explicitly reaffirmed in its coalition agreement from April 2025 the importance of the healthcare industry and the willingness to continue the dialogue.
The launch of the Pharma & MedTech Dialogue follows a quite active legislative period in the previous federal government marked by significant regulatory activity for the life sciences sector. These were introduced, inter alia, by the Digital Act (DigiG), the Health Data Use Act (GDNG; see our earlier blog) and the Medical Research Act (MFG), which we have also discussed in an earlier blog). With the revived Pharma and MedTech Dialogue, the new German Government seeks to build on the initiatives of its predecessor and aims to develop a favorable regulatory environment for the life sciences sector in Germany.
II. Two-Page Concept, Multi-Year Expectation – What’s in it?
The Federal German Government’s Pharma and MedTech Dialogue builds on surprisingly concise documents: A two-page concept paper and a three-page FAQ paper, which contains little additional information. This shows that the Government aims to largely continue the pharma strategy of the previous government, which was set out in December 2023 in significantly more detail.
Despite its brevity, the concept paper for the Pharma and MedTech Dialogue reveals the ambitious objectives of the subsequent Pharma and MedTech Strategy. Aimed at strengthening the competitiveness of Germany as a location for the life sciences sector, the Government seeks to:
- improve the framework conditions for the development and production of pharmaceuticals, API, medical devices and technologies in Germany,
- promote digitalization and the use of AI in the pharmaceutical and medical technology industries (notably, reference is made specifically to the industry, practically excluding public bodies),
- reduce regulatory and bureaucratic barriers,
- create sustainable framework conditions for research and development.
At the same time, the dialogue process is intended to identify measures to ensure the availability and sustainable financing of both innovative and generic drugs in Germany. In addition, the process is expected to identify approaches to mitigate further increases in statutory health insurance premiums.
III. Six Working Groups
The operational work of the Dialogue is carried out by six topic‑specific working groups, each composed of representatives from the life sciences industry, public health insurances, ministry representatives and other stakeholders. The working group structure aligns with the Federal Government’s goal of developing “specific recommendations for action” by the second half of 2026.
The topics that the Federal German Government has assigned to each working group (WG) concern the following areas:
- WG 1 – “Supply of patent-free medicinal products; overarching location issues, financing, security of supply, and supply chains”
- WG 2 – “Digitalization, Research with health data, Clinical research, AI”
- WG 3 – “Benefit assessment [AMNOG] and EU HTA”
- WG 4 – “Pricing and reimbursement of new drugs”
- WG 5 – “Biotechnology and clinical trials”
- WG 6 – “MedTech and Medical Devices”
IV. Key points raised by the Life Sciences Industry
While the working group meetings are taking place behind closed doors, several key issues have emerged that industry representatives from Pharma and MedTech seek to address in the working group sessions.
Pharma stakeholders advocate as a general theme for less bureaucracy in the entire sector, including for clinical trials and other research. They also speak out for more acceptance of real‑world data (RWD) and better support for innovation using known substances. They also call for closer alignment between the German AMNOG procedure and the EU HTA process and a swift national rollout of the electronic Patient Information Leaflet (ePIL) and the electronic Instructions for Use (eIFU).
Regarding the Government’s call for more local manufacturing, industry circles report that the discussion was to include the request for quicker approval procedures for manufacturing sites and improved conditions for production in Germany.
On pharmaceutical market access matters, the industry is reported to seek a revision of the AMNOG process. On the pricing and reimbursement side of the AMNOG procedure, this request includes the removal of the pricing guardrails for drugs with new active ingredients. Also, industry representatives suggest new pricing approaches such as pay-for-performance models. Furthermore, there is a continued pressure from the industry to abandon the mandatory 20% discount for combination drug therapies.
The MedTech sector representatives are reported to focus on the upcoming reform of the MDR and IVDR, which has currently been initiated by a reform proposal of the European Commission.
As we reported in a recent blog, the Commission aims to make the rules “easier, faster and more effective and further promote competitiveness, innovation and a high-level of patient safety.” Thus, it is crucial for MedTech companies to use the Dialogue as a platform to help shape Germany’s position in the upcoming deliberations of the reform.
V. Statutory Health Insurers highlight increasing financial burden
From another side of the working groups’ round table, the AOK group, a group of eleven public health insurance funds with a significant market share in Germany, expressed that against the background of rising costs for the German public health care system, price regulating mechanisms would need to be upheld and, in some cases, even extended.
Already before the Dialogue’s launch, the AOK proposed a temporary increase in the mandatory manufacturer rebate from 9% to 16%. In a later position paper, the AOK called for further measures. These include a reform of the 6-month free pricing period which drugs with new active ingredients benefit from in Germany. Furthermore, it would like the lawmaker to uphold the pricing guardrails for reimbursement prices and have the option for a confidential reimbursement price, which we have reported on in an earlier blog, withdrawn.
At the same time, there is currently quite a surge in interest in the option for a confidential reimbursement price agreement because of the Most-Favoured-Nation (MFN) pricing developments in the U.S.
VI. Outcome of the working group sessions
While the conflicting interests are obvious, each working group is to formulate common recommendations for action (“gemeinsame Handlungsempfehlungen”) within its respective subject area once the meetings are concluded. The recommendations are to be consolidated in an inter-ministerial process and are expected to culminate in the Federal Government’s Pharma and MedTech Strategy in the second half of 2026.
Industry associations have indicated that they also intend to submit their own statements to the Government. However, it remains uncertain whether such external submissions will be reviewed and can influence the final Strategy.
As the dialogue progresses, it is becoming increasingly evident that the process relies heavily on extensive coordination and consensus‑building. This may help ensure broad participation but also introduces additional procedural complexity. Ultimately, the format appears very broad and operationally heavy which increasingly raises scepticism whether its outcome will really translate into meaningful and actionable progress. Some industry representatives already express frustration that this dialogue process will not lead to relevant improvements.
VII. Key Takeaways for the Industry
- The new Pharma & MedTech Dialogue is broader and more ambitious than previous initiatives.
- For the first time in the dialogue format, MedTech is significantly involved. However, the most pressing regulatory needs of the German medical device industry are currently focused on the imminent reform of the EU Medical Device Regulation and the IVD Regulation. The German Government is expected to be vocal in Brussels when the reform proposal of the European Commission will be deliberated.
- The process is aimed to culminate in a comprehensive strategy with potential legislative effects reaching well into 2027. Currently, it is not really foreseeable (and not only we are sceptical) whether the dialogue will really lead to significant regulatory reforms.
- Drug pricing & reimbursement remains a hot topic on the agenda.
- The health insurances push for additional (and substantial) measures to limit the spend for drugs.
- Also, in the light of persisting budget constraints of the health insurance system and pressure on the German Government, the pharmaceutical industry should be prepared for new cost containment measures in the near term.
VIII. What happens next?
As the working groups continue their deliberations, the coming months will determine whether the Pharma & MedTech Dialogue can move beyond process and deliver genuine regulatory momentum.
First consolidated results of the Pharma & MedTech Dialogue are expected by mid‑2026. Based on that, the finalized Pharma and MedTech Strategy is expected by Q3/Q4 2026.
Insofar, pharmaceutical and medical devices companies should prepare for a period marked by ongoing consultations and potentially early initiatives of the German Government. The industry should keep a close eye on the next developments and outcomes of this Dialogue process while being vigilant that the most consequential policy steps (e.g., cost-containment measures) may well emerge outside of it.
The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will keep you posted about the next developments and stands ready should you have questions on Germany’s Pharma and MedTech Dialogue or its implications for your business.
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