1. What is the current legal landscape for your practice area in your jurisdiction?

The Danish life science landscape is characterized by active strategic transactions, a selective but tight funding environment, and an ambitious regulatory and industrial policy framework at both EU and national level.

Deal activity is gradually increasing, with a clear trend towards in- and out-licensing as companies seek to de-risk pipelines and access external innovation. At the same time, competition for attractive assets is intense: Novo Nordisk recently stepped back from the bidding for Metsera, which was ultimately acquired by Pfizer, and Lundbeck has chosen not to increase its offer in a contested bid for Avadel in Ireland. These examples illustrate how aggressively major players now pursue high-value opportunities.

Funding conditions for early-stage biotechs remain difficult. Smaller Danish and Nordic funds have struggled to raise new capital, and the number of companies surviving on seed funding for extended periods has grown, creating a structural gap in the EUR 25–50 million range, while larger international investors typically focus on substantially higher ticket sizes. This puts pressure on management to secure strategic partnerships and to be disciplined on valuation, structure and timing of transactions.

In parallel, Denmark is strengthening its framework for research, data and manufacturing. The “Strategy for Life Science towards 2030” includes, among other measures, a “red carpet” initiative for major manufacturing investments and a broader effort to position Denmark as a leading location for clinical research and high-value production. On the data side, Digital Sundhed Danmark is being established as ét kontaktpunkt for applications concerning secondary use of health data, with a national secure analysis platform so that companies and researchers can apply once for access to data from multiple public controllers and work in environments suited for advanced analytics and AI. This is a central element of Denmark’s preparations for the European Health Data Space. At the same time, a new 14-day assessment timeline for mono-national Phase I and integrated Phase I/II clinical trials, with parallel review by the Danish Medicines Agency and the ethics system, now sets a European benchmark for early-phase approvals.

All of this is layered on top of an evolving EU framework: MDR/IVDR, the proposed reform of the general pharmaceutical legislation, the AI Act, the Data Act and the EHDS Regulation, together with horizontal regimes such as CSRD/ESRS. Denmark tends to implement EU law early and comprehensively, and CSRD in particular is seen as administratively demanding, drawing significant internal resources into documentation and reporting.

2. What three essential pieces of advice would you give to clients involved in your practice area matters?

First, stay ahead of regulation but think holistically and prioritize. It is rarely efficient to run separate projects for GDPR, cyber security, NIS2, the Cyber Resilience Act, MDR/IVDR and pharmaceutical rules. Clients should aim for a coherent governance model that creates synergies across these regimes and focus resources where risks and overlaps are greatest, especially around digital products and data use.

Second, accept that compliance is burdensome and treat it as core risk management rather than a peripheral cost. The regulatory and enforcement risk level in life sciences is higher than it used to be, and robust governance, documentation and audit trails are now essential to protecting value, defending decisions vis-à-vis regulators and counterparties, and remaining attractive to investors and partners.

Third, invest in resilience – in cyber security, supply chains and sustainability. Strengthening protection around sensitive data and digital infrastructure, reducing single-point dependencies and unnecessary geopolitical exposure in supply chains, and meeting or anticipating sustainability expectations under CSRD and broader ESG scrutiny are increasingly central to license to operate and long-term competitiveness.

3. What are the greatest threats and opportunities in your practice area law in the next 12 months?

Cyber risk is one of the most immediate threats. Highly digitalized operations, connected devices and large volumes of health data mean that ransomware, data breaches and supply-chain attacks can quickly turn into regulatory, contractual and reputational crises, particularly as NIS2 and the Cyber Resilience Act tighten requirements on governance and product security.

A second threat is implementation fatigue and “regulatory whiplash”. In the next year, important secondary legislation and guidance will be developed under the AI Act, EHDS, the Data Act and the pharma package, while there is simultaneous political pressure to adjust parts of the digital rulebook in the name of competitiveness. The risk lies less in any single law than in uncertainty and re-work: businesses that implement too narrowly may be forced to revisit work repeatedly, while those that delay may be unprepared when enforcement starts. Combined with a difficult funding environment, heightened expectations on security of supply and growing ESG scrutiny, this creates a convergence of legal and operational pressure.

On the opportunity side, there is clear potential in implementing AI intelligently to optimize workflows in regulatory affairs, pharmacovigilance, quality and clinical operations, provided solutions are designed with AI Act, MDR/IVDR and GDPR requirements in mind from the outset. Companies can also leverage Denmark’s fast early-phase clinical pathway and emerging health-data infrastructure to run data-rich, early-phase studies and to strengthen real-world evidence. In addition, in a stressed funding market, well-prepared buyers may identify scientifically strong but capital-constrained assets and structure attractive partnerships or acquisitions around them.

4. How do you ensure high client satisfaction levels are maintained by your practice?

We focus on staying ahead of regulatory developments and translating them into clear, business-oriented guidance. Horizon scanning across the pharma package, MDR/IVDR, the AI Act, the Data Act, EHDS, NIS2, CSRD and national initiatives is followed by concise impact assessments focused on what new rules mean for a client’s products, pipeline and transactions.

Our advice is deliberately cross-disciplinary. We connect regulatory, data/AI, cyber, ESG and transactional perspectives so that clients receive one coherent view rather than fragmented input from different specialists. Matters are scoped tightly and linked to specific commercial decisions, with an emphasis on predictable fees and deliverables that can be reused internally, such as templates, playbooks and governance frameworks.

Finally, we invest time in understanding each client’s business model, markets, financing situation and risk appetite, so that our advice is aligned with management and board priorities and supports coordination between legal, regulatory, compliance, business development and finance.

5. What technological advancements are reshaping your practice area law and how can clients benefit from them?

Artificial intelligence is already reshaping the legal and regulatory framework. Under the AI Act, most AI used in medical devices, diagnostics and clinical decision support will be categorized as high-risk and must meet demanding requirements for risk management, data quality, transparency, human oversight and post-market monitoring, in addition to MDR/IVDR and GDPR. For clients, the opportunity lies in using AI to streamline internal processes and enable more advanced clinical and commercial solutions, while building governance and documentation that satisfy these regimes in a coordinated way and can be presented as a quality mark rather than a constraint.

Quantum computing is a more emerging, but increasingly relevant, development for simulation-intensive areas such as molecular modelling and protein folding. In practice, access will initially come via CROs, cloud providers and technology partners rather than in-house hardware, but it is timely for clients to consider how intellectual-property and data rights, regulatory validation and contracting should be structured around quantum-enabled discovery and development. Clients who combine careful governance with early, pragmatic adoption of these technologies are likely to be best placed to turn a demanding legal environment into a competitive advantage.