Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

Latest from Inside EU Life Sciences

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 Germany.

I.          Background

In

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

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.

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 will constitute quantifiable and fungible

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 annual study tracks these deals

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 become popular in the U.S.

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 significant development in the regulation of

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 to improve pandemic preparedness and

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

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 genetic resources (“DSI”).  Large companies