Pharma

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