Pharmaceutical companies

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…

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…

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?


Over the past week, at the 79th World Health Assembly (“WHA”) in Geneva, governments have been debating one of the most consequential but still poorly understood elements of the World Health Organization (“WHO”) Pandemic Agreement that was adopted in May 2025: the Pathogen Access and Benefit-Sharing (“PABS”) System.  Since…

Continue Reading The World Health Organization’s Emerging Pathogen Access System: Implications for Commercial Infectious Disease R&D

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.

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…

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…

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

Introduction

On 16 December 2025, the European Commission (“Commission”) published its Proposal for a Regulation on establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors particularly in the area of health (“Biotech Act”) (see here).  The Proposal follows a public consultation held between…

Continue Reading European Commission Adopts Proposal for the Biotech Act

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…

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

On 1 December 2025, the UK Government announced a “landmark” UK-US pharmaceutical deal.   Under the deal, the UK claims to be (so far) the only country to secure zero-percent tariffs on pharmaceuticals exported to the US for the next three years.  In return, the UK has committed to increase its…

Continue Reading Landmark UK-US Pharmaceutical Deal