In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second, the court treats promotional social media reels/videos
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EU Announces Political Agreement on Pharma Law Review
At just after 5 am on 11 December 2025, the EU Parliament and the Council reached agreement on a new directive and a new regulation that will result in a major update to the EU’s pharmaceutical laws. Progress towards these new rules began in 2016 and are the result of over two years of negotiations
Landmark UK-US Pharmaceutical Deal
On 1 December 2025, the UK Government announced a “landmark” UK-US pharmaceutical deal. Under the deal, the UK claims to be (so far) the only country to secure zero-percent tariffs on pharmaceuticals exported to the US for the next three years. In return, the UK has committed to increase its spending on medicines and revise
Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon
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
MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
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
MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation
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.
An 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 will constitute quantifiable and fungible
Synthetic 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 annual study tracks these deals
Non-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 become popular in the U.S.
China’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 significant development in the regulation of