This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.
On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech
Continue Reading European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicinesOn 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.
Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.
We have set out some of the discussion from the sessions below.
European Life Sciences – The Changing Landscape for Pharma and Biotech
Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.
The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).
The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.
There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.Continue Reading The Covington European Life Sciences Symposium 2025
On 11 July 2023 the National Security Act 2023 (the Act) received royal assent and became law. The Act addresses trade secret misappropriation in the context of industrial espionage by a foreign government, making the unauthorised conduct of obtaining, copying, recording or retaining a trade secret, or disclosing or providing access to a trade secret, under certain circumstances, a criminal offence. The maximum penalty is 14 years imprisonment and/or a fine (section 2 of the Act).
The trade secrets provision is part of a broader regime introduced by the UK government to address national security threats such as espionage, sabotage and foreign interference.
One of the conditions that has to be met in relation to the person’s conduct is the “foreign power condition”. The foreign power condition is defined in section 31(1) of the Act as:
(a)the conduct in question, or a course of conduct of which it forms part, is carried out for or on behalf of a foreign power, and
(b)the person knows, or having regard to other matters known to them ought reasonably to know, that to be the case.
In order for section 31(1) to be triggered it is for example sufficient if the conduct is under direction or control of the foreign power or even just carried out with the financial or otherwise assistance provided by a foreign power for that purpose.
It will be interesting to see how the foreign power condition will be applied in practice, in particular where governments have extensive control and ownership over corporations.Continue Reading Trade secrets misappropriation: a new criminal offence in the UK