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 horizonAn EU Biodiversity Market by 2027? The new EU’s Roadmap towards Nature Credits
On July 7, 2025, the European Commission presented its Roadmap Towards Nature Credits, setting the blueprint for biodiversity certification in the EU. The Communication was also accompanied by a Q&A and a call for feedback by 30 September 2025.
Nature Credits: Practical Uses Across Sectors
In short, nature credits
Continue Reading An EU Biodiversity Market by 2027? The new EU’s Roadmap towards Nature CreditsSynthetic Royalty and Drug Development Financings – A Funding Structure Growing in Europe
Biotech companies are always searching for new ways to fund the costly and uncertain process of drug development and product launch. Over the past several years, synthetic royalty and drug development financings have become an additional option for fundraising, as traditional equity markets have remained challenging. Covington & Burling’s third
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Quantum Computing and its Impact on the Life Science Industry
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 IndustryNon-Dilutive Financing: The U.S. Trend Catching on in Europe’s Life Sciences Sector
Raising capital to discover, develop, and commercialize new drugs has always been a regular feature for life sciences companies, and the current environment of tight equity markets and lower company valuations has caused significant strains. In response, many European life sciences businesses are turning to non-dilutive financing options that have
Continue Reading Non-Dilutive Financing: The U.S. Trend Catching on in Europe’s Life Sciences SectorChina’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know
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 KnowWhat Companies Should Know About the WHO Pandemic Agreement
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 AgreementThe Cali Fund and Why Legal Certainty Matters for Life Sciences R&D
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
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Re-Launch of UK’s Innovative Licensing and Access Pathway (“ILAP”)
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.
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MHRA Consultation on Individualised mRNA Cancer Immunotherapies – Unique opportunity for a streamlined risk based regulatory framework?
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?