life sciences

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

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

Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in…

Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon

Quantum computing uses quantum mechanics principles to solve certain complex mathematical problems faster than classical computers.  Whilst classical computers use binary “bits” to perform calculations, quantum computers use quantum bits (“qubits”).  The value of a bit can only be zero or one, whereas a qubit can exist as zero, one, or a combination of both states (a phenomenon known as superposition) allowing quantum computers to solve certain problems exponentially faster than classical computers.

The potential applications of quantum computing are wide-ranging and industry-agnostic. For instance, they could be used to enhance the analysis of large, complex data sets, optimize supply-chain processes, and enhance artificial intelligence (“AI”) technologies and improve machine learning algorithms.

Given the potential applications, quantum computing could have a significant impact on companies in the life sciences sector, and more specifically could be used to improve:Continue Reading Quantum Computing and its Impact on the Life Science Industry

The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic.  In the aftermath of the pandemic, there have been repeated calls for more joint procurement.  This blog explores the existing mechanisms for joint procurement and also considers the Commission’s proposal for a Critical Medicines Act (“CMA”) and what it would mean for public procurement.

At a high level, there are already various mechanisms for joint procurement of medicinal products and medical devices both with and without involvement of the Commission.  The CMA proposal does not fundamentally change that but rather supplements the existing regimes.

The key aspect to be aware of is that both the existing regime and the draft CMA merely establish a framework for joint procurement, including the relationship among Member States and the Commission (if involved).  This framework focusses on establishing when joint procurement is possible and the mechanism for getting a joint procurement set up.  However, the framework does not specify in what circumstances Member States and/or the Commission might choose to engage in joint procurement, the terms of the tender or any resulting contract.Continue Reading EU Joint Procurement – An Overview

On 30 January 2025, the UK Government announced the re-launch of the Innovative Licensing and Access Pathway (“ILAP”) for medicines.

The ILAP is an “end-to-end” access pathway offering a unique opportunity for a medicine’s developer to engage with: (i) the UK’s medicines regulator – the Medicines and Healthcare products Regulatory Agency (“MHRA”); (ii) England’s HTA body – the National Institute for Health and Care Excellence (“NICE”); and (iii) and the National Health Service (“NHS”) (together the “ILAP Partners”).  By providing medicines developers with joined-up, co-ordinated and tailored guidance from the ILAP Partners, from the early stages of clinical development, the ILAP scheme hopes to accelerate the time to market for innovative and transformative medicines and drug-device combinations.Continue Reading Re-Launch of UK’s Innovative Licensing and Access Pathway (“ILAP”)

The UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) is seeking industry feedback on its new draft guideline on individual messenger ribonucleic acid (“mRNA”) cancer immunotherapies (the “Draft Guidance”).  Building on the success of mRNA vaccine technology in response to the Covid-19 pandemic, the technology is now being adapted to target diseases such as cancer.  The MHRA aims to provide a streamlined robust regulatory framework for the approval of such personalised mRNA-based cancer vaccines without compromising safety.

The Draft Guidance covers the regulatory classification of these novel cancer treatments, product design and manufacture, non-clinical and clinical development, pharmacovigilance and the distribution of information to the wider public.  Notably, the MHRA explicitly acknowledges that the regulatory and scientific principles discussed in the Draft Guidance could broadly apply to other disease indications or technologies that could benefit from personalisation or individualisation.  Therefore, industry should be aware that the scope of the Draft Guidance may be extended in the future beyond mRNA cancer immunotherapies that use lipid nanoparticle delivery systems to other delivery systems and disease areas.  Manufacturers, developers, patient organisations and other stakeholders have until 31 March 2025 to comment on the Draft Guidance.

We explore some of the interesting regulatory considerations arising from the Draft Guidance below.Continue Reading MHRA Consultation on Individualised mRNA Cancer Immunotherapies – Unique opportunity for a streamlined risk based regulatory framework?