Pharma

Hot off the press, yesterday evening, 29 September 2026, the German Government’s expert committee presented the eagerly awaited proposal for a new “location clause” (Standortklausel) to incentivize pharmaceutical R&D and manufacturing in Germany. Under this proposal, pharmaceutical companies can apply for a reduction or complete waiver of the just recently enacted 8.5% additional “manufacturer markdown” (Herstellerabschlag). So, what does this newly proposed German location clause mean for pharmaceutical companies?

This blog outlines the proposed location clause and summarizes initial stakeholder reactions. We also discuss whether the proposal would really be an improvement for pharmaceutical companies or rather a bureaucratic worsening compared to the currently applicable exemption.

Continue Reading Germany Reviews a New Pharma “Location Clause” (Standortklausel) for Pricing & Reimbursement Incentives – Improvement or Worsening for the Pharmaceutical Industry?

The global biotechnology landscape is evolving at an unprecedented speed, driven by advances in synthetic biology and genome editing, which, coupled with AI, make biotechnology stand at the forefront of innovation.  These developments offer unprecedented opportunities for advancing health and protecting against biological threats, but also make biotechnological misuse faster, cheaper, and more accessible.  For that reason, the European Commission has proposed the introduction of a new Union-level framework on biodefence and the prevention of biotechnology misuse in the European Biotech Act (the “Biotech Act”).

Continue Reading The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology Companies

Tomorrow, on 30 July 2026, the “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) will enter into force, marking the culmination of a fast-paced and politically contentious legislative process. The reform, which has attracted significant attention, introduces a broad package of cost-containment measures across the statutory health insurance (GKV) system. Several of these specifically target pharmaceutical spending and reimbursement and are highly relevant for pharmaceutical companies.

This blog discusses the new measures with direct relevance for manufacturers and highlights the key changes made between the draft and the final law. In our earlier blog from 28 April 2026, we have discussed the key elements of the draft GKV-BStabG and its potential implications. The final law retains the overall direction of the reform but introduces several important adjustments that will impact pharmaceutical companies.

Continue Reading What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?

Anderson Ribeiro, Aline Ferreira and Henryk Trelinski of Souto Correa Advogados contributed to the preparation of this article.

Foreign companies have long faced a practical challenge under Brazil’s access and benefit-sharing (“ABS”) regime: although registration obligations apply to activities involving Brazilian genetic heritage, foreign legal entities still cannot register…

Continue Reading Brazil delays SISGEN 3.0 Foreign-User Functionality while Government Advances alternative pathway for foreign ABS Compliance

I. Background – From Pharma-Dialogue to Compulsory Price Cuts

Tomorrow, on 29 April 2026, the German Government is expected to adopt a new law to stabilize the finances of the statutory health insurances. This draft law titled “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) proposes manifold cost-containment measures that would also significantly impact pharmaceutical companies. As such, the new law inter alia proposes new (tightened) pricing rules and compulsory markdown payment obligations for drug companies.

The GKV-BStabG proposes a mix of spending cuts and revenue-increasing measures projected to save the German healthcare system almost €20 billion in 2027 and more than €42 billion by 2030. The cuts in pharmaceutical spending are expected to contribute around €1.9 billion savings in 2027.

The scope of the proposed cost containment measures appears to have hit the German pharmaceutical industry a bit off-guard. Over the last months, the German Government had initiated a Pharma & MedTech Dialogue (see our earlier blog on this dialogue) that gave hope that the Government was open to listen to the industry needs. While the GKV-BStabG is not final and will likely evolve during the legislation process, it clearly shows the Government’s primary interest in short-term cost-cuttings.

This article outlines the key proposals in the GKV-BStabG affecting the pharmaceutical industry and provides an overview of the roadmap of the legislation process. The proposed reform in Germany may also interfere with other international trends like the Most-Favored-Nation (MFN) pricing developments in the US.

Continue Reading Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?

Introduction

As discussed in our previous blogpost (link), on 16 December 2025, the European Commission (“Commission”) released its Proposal for the European Biotech Act (“Biotech Act”) (see here). 

This blogpost focuses on Chapter II of the Proposal (“Union Health Biotechnology and Biomanufacturing”), which introduces a framework for the recognition of “health biotechnology strategic projects” (“Strategic Projects”) and “high impact health biotechnology strategic projects” (“High Impact Strategic Projects”), together with a package of regulatory and support measures aimed at accelerating their development and deployment in the Union.

Continue Reading The Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology Sector

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.

Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects

On November 5, 2025, the Spanish Ministry for Ecological Transition and Demographic Challenge (“MITECO”) adopted a Resolution setting out the National Plan for the control of compliance with access and benefit-sharing (“ABS”) obligations under Regulation 511/2014 implementing the Nagoya Protocol in the European Union.  The National Plan sets out a “risk-based” control system to ensure that life sciences companies in, e.g., the pharmaceutical, plant breeding, cosmetic and other sectors operating in Spain utilize genetic resources (“GRs”) and associated traditional knowledge (“ATK”) in compliance with ABS rules of the country where the GRs and ATK are accessed. We provide more details below.

Building on the existing ABS framework in Spain, and in particular on the Royal Decree 124/2017, the MITECO adopted a National Plan setting out a “risk-based” control system, mandating the competent authorities of the Autonomous Communities (“the authorities”) to perform controls on users of certain sectors that are more likely at risk of utilizing GRs and ATK in violation of ABS rules.  

Continue Reading ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules

This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.

On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech…

Continue Reading European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicines

In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second, the court treats promotional social media reels/videos like TV ads which leads to subsequent disclosure obligations. Third, influencers can regularly qualify as “known persons” so that the restrictions under German law for drug advertising with known/famous persons can apply. Continue reading for more details on the case and its implications for pharmaceutical companies.

Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media