On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”).  Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval – in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025).

Continue Reading MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices


On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation.  The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices in Great Britain, with this consultation expected to take place later in 2025.

Continue Reading MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation


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 Credits

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…

Continue Reading Synthetic Royalty and Drug Development Financings – A Funding Structure Growing in Europe

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:

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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 Sector

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…

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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…

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