Life Sciences & Digital Health

On August 28, 2026, the California Legislature unanimously passed Assembly Bill 2244 (AB 2244) to establish a voluntary state certification program for non-ultraprocessed foods (non-UPF). Governor Gavin Newsom has until September 30, 2026, to sign or veto the measure. If enacted, AB 2244 would direct the California Department of Public…

Continue Reading California Passes Bill to Create State Seal for “Non-Ultraprocessed” Foods

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

Executive Summary

On August 22, 2026, U.S. tariffs of 50 percent imposed under Section 338 of the Tariff Act of 1930 (19 U.S.C. § 1338) took effect against a range of imports from Canada, including chemicals, prepared food and beverages, plastics, metal items, machinery, cosmetics, wood and paper products, industrial…

Continue Reading Section 338 Tariffs on Canada Take Effect as Canada Announces Retaliatory Response

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?

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?

On January 8, 2026, Brazil published Law 15,330/2026, officially recognizing açaí berry as a Brazilian national fruit in a bid to protect it from so-called “biopiracy”, i.e., the illegal exploitation of genetic resources and traditional knowledge (“ATK”).  Açaí berry is a ‘superfood’ rich in nutrients which grows almost exclusively along the Amazon River, and particularly in Brazil, its largest producer and exporter, producing about 1.74 million tons of açaí and generating around BRL 7.7 billion in 2024.

The legislative recognition of açaí berry as a national fruit – following the earlier designation of cupuaçu in 2008, which itself responded to attempts to register “cupuaçu” as a trademark in Japan – is largely symbolic in nature.  Law 15,330/2026 does not introduce new substantive rights or regulatory mechanisms, as Brazil already comprehensively governs access to genetic resources and the sharing of benefits arising from their use, under Law 13,123/2015 and through its implementation of the Nagoya Protocol.  Its practical significance therefore lies less in creating additional protection than in drawing renewed political and public attention to the enforcement of Brazil’s existing access and benefit‑sharing regime.

Continue Reading Brazil declares Açaí a National Fruit: What Are the Real Practical Implications for EU 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

On November 12, 2025, UNESCO’S General Conference adopted its Recommendation on the Ethics of Neurotechnology (“the Recommendation”)–the first attempt at establishing a global legal framework for the ethical development and use of neurotechnology. The Recommendation aims to set out a comprehensive rights-based framework for the entire life cycle of neurotechnology, from the design of neurotechnology products and services to their disposal.

While not legally-binding, the Recommendation states that its provisions should be considered by, among others, UNESCO Member States, research organizations, and private companies involved in neurotechnology, and that they establish how best to honor fundamental human rights in the development, deployment and disposal of this technology. It is therefore possible that in the future, they may be a starting point for binding legislation, or could be used as persuasive authority to support enforcement actions arising under existing legislation protecting fundamental human rights, e.g., the GDPR and other privacy laws around the world. In that regard, it is notable that the EU AI Act was inspired, at least in part, on UNESCO’s November 2021 Recommendation on the Ethics of Artificial Intelligence. There is, therefore, a real possibility that private sector companies developing neurotechnologies will be subject to rules specifically regulating such technologies in the future.

Continue Reading UNESCO Adopts First Global Framework on Neurotechnology Ethics