Legal Affairs Committee Meeting

Dear member,

We are thrilled to invite you to the first meeting in the Legal Affairs Committee.

You can nominate one representative with relevant responsibility and decision-making authority to participate in the Committee by responding to Pernille Schmidt on ps@danskbiotek.dk.

Invitation

The legal digital landscape is evolving heavily these years as part of the EU’s Digital Strategy. In combination with the geopolitical tensions and the cyber threats organisations are facing, not least bio tech companies, we are pleased to welcome you to an exciting programme on 25 June 2025 at 8:30-12:00 at Bech-Bruun’s offices in Nordhavn (Gdanskgade 18, 2150 Nordhavn).

The programme is:

8:30-9:00: Registration

9:00-9:10: Welcome and short introduction to the legal digital landscape as of 2025 by Mikkel Friis Rossa, partner Bech-Bruun

9:10-10:00: NIS2 – How will the EU’s new cybersecurity rules affect biotech? Join us for a practical session on the NIS2 Directive and what it means for biotech companies working with research, medicine, and data. We will break down the legal obligations and highlight key compliance steps – and the authorities’ expectations in relation to documentation of compliance. Finally, we will discuss what boards and management need to know about their roles and responsibilities. Mikkel Friis Rossa, partner Bech-Bruun

10:00-10:45: Are you ready for the EU Data Act? Data Act introduces new rules on access to and sharing of data. This can entail significant impact on biotech companies handling connected devices, research platforms, and industrial data. This session will explain the key obligations, including data access rights, contractual requirements, and what you need to do to ensure compliance in time. Dan Bjerg Geary, partner Bech-Bruun.

10:45-11:00: Break

11:00-11:50: The Negotiation Paradox (cybercrime). There are many opinions when it comes to communicating and even negotiating with Threat Actors (TA). Often, the victim is strongly recommended NOT to engage with the TA. This talk will give you a unique insight into examples from real-life cases where TA communication assisted the technical investigation and vice-versa. The talk will include technical and strategic elements within Incident Response, and you will understand why TA communication is not the same as paying a ransom. In fact, sometimes, TA communication is the only way to understand the entire risk set associated with the incident. Jan Kaastrup, partner at CSIS, and Michael Sjøberg, Human Advisor Group.

11:50-12:00: Q&A and sum up

Please respond before 23 June 2025 if you wish to participate.