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 March 5, 2025, the Regulation on the European Health Data Space (“EHDS”) was published in the Official Journal (see here).  The text enters into force on March 25, 2025, however it only becomes applicable in a staggered manner over several years.

The section on secondary use of the…

Continue Reading European Health Data Space Published

On 29 January 2025, NHS England (“NHSE”) published an updated Commercial Framework for New Medicines (the “Commercial Framework”). The Commercial Framework, first published in 2021, sets out NHSE’s approach to commercial activity in relation to new branded medicines and is a key document in the UK’s pricing and reimbursement landscape.

The Commercial Framework clarifies and consolidates a number of points, as well as introducing new changes. Continue Reading The Updated NHS Commercial Framework for New Medicines

On February 26, 2025, the Cali Fund was officially launched.  Established by the 196 parties to the Convention on Biological Diversity (“CBD”), the Cali Fund invites pharma, cosmetics, food, AI, plant breeding, animal breeding, biotech, and other companies to “share monetary benefits” from uses of digital sequence information on…

Continue Reading The Cali Fund and Why Legal Certainty Matters for Life Sciences R&D

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?

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.Continue Reading The Covington European Life Sciences Symposium 2025

On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers

On 18 December 2024, the European Commission published a proposed implementing regulation relating to pharmacovigilance (“PV”) requirements for human medicines marketed in the EU (“Proposal”), which will update European Commission Implementing Regulation (EU) 520/2012 (“Implementing Regulation”).  While the core PV requirements, including the obligation to establish and operate a PV system and the key reporting requirements, are set out in Regulation (EC) No 726/2004 and Directive 2001/83/EC, the Implementing Regulation provides detailed requirements on the performance of PV activities, including the need for a PV system master file (“PSMF”), more comprehensive requirements for the PV quality system, and detailed provisions relating to periodic safety update reports (“PSURs”). 

The proposed changes aim to harmonize the performance of PV activities by marketing authorization holders (“MAHs”), national competent authorities and the European Medicines Agency (“EMA”), and in some cases widen the scope of the Implementing Regulation’s PV requirements.  Other changes are clarificatory in nature.Continue Reading European Commission Consults on Update to Pharmacovigilance Rules

The Secretariat of the Convention on Biological Diversity (CBD) has opened four consultations inviting stakeholder input on the development of the new Multilateral Mechanism on Benefit-Sharing (MLM) for Digital Sequence Information (DSI), including the establishment of the global benefit-sharing fund known as “The Cali Fund.”  

Companies are encouraged to…

Continue Reading Just Weeks After COP16: CBD Secretariat Launches Stakeholder Consultations for the Operationalization of the DSI Mechanism. How Should Companies Engage?