On April 29, 2025, China released a landmark draft of its first unified Environmental Code, now open for public consultation until June 13, 2025. The 2025 Draft Environmental Code (“Draft Code”) consolidates and elevates into a single legal instrument many of China’s environmental laws, but it also marks a…

Continue Reading China’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know

Image Credit: World Health Organization

On 16 April 2025, Member States of the World Health Organization (WHO) concluded negotiations on a new international treaty: the Agreement on pandemic prevention, preparedness and response (“WHO Pandemic Agreement”). Set to be adopted at the May 2025 World Health Assembly, this landmark accord aims…

Continue Reading What Companies Should Know About the WHO Pandemic Agreement

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