1. What is the current legal landscape for Life Sciences Law in your jurisdiction?

Sweden operates within an increasingly dynamic legal landscape shaped by EU regulations and national policies. At EU level, the revision of pharmaceutical legislation, the MDR and IVDR, the implementation of, amongst others, the AI Act and the EHDS are redefining market access, compliance obligations and data use. In parallel, the Corporate Sustainability Reporting Directive (CSRD) and the associated European Sustainability Reporting Standards are imposing substantial documentation and reporting requirements on Life Sciences companies, drawing significant internal resources into sustainability compliance and increasingly forming part of the broader regulatory burden alongside sector-specific obligations.

Sweden benefits from a high-performing healthcare system, advanced digital infrastructure and leading research environments, to name but a few, including SciLifeLab, Max IV, the European Spallation Source and the National Academic Infrastructure for Super­computing in Sweden (NAISS), and one can observe a shared commitment across industry, government and academia to realise this ambition.

With the ambition of being a strong Life Sciences nation, a number of initiatives have been established at national level. An expanded state responsibility for pharmaceuticals has been proposed with the aim of strengthening the introduction of new medicines and promoting equitable access to care. Declining clinical trial activity has prompted the establishment of a national partnership for clinical trials, aimed at increasing the number of high-quality trials, though whether this will suffice to reverse the trend remains to be seen, particularly as competing neighbouring jurisdictions have introduced accelerated assessment timelines for early-phase trials. The transition from research to commercial scale-up remains a weakness, though recent investments in innovation hubs such as NorthX Biologics and CCRM Nordic are intended to strengthen translational capacity. New tax incentives for research and development are also under consideration which, if introduced, may improve framework conditions for both Swedish and foreign companies. Also, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has established a new reimbursement framework for orphan drugs through a rarity index under which significantly higher incremental cost-effectiveness ratios (ICERs) have been accepted (up to SEK 4.3 million per quality-adjusted life year) with five products included to date, signalling an evolving willingness to accommodate the particular economics of rare disease treatments within the Swedish system.

In Sweden, there is a clear policy ambition to actively pursue EU measures that strengthen competitiveness and support research, development and production of pharmaceuticals and medical devices. A key challenge concerns the governance and use of health data. Despite strong assets such as national quality registries, biobanks and high digital maturity, Sweden lacks a coherent framework for secondary use. A commission of inquiry has been tasked with facilitating a national digital infrastructure for the healthcare system.

A further structural factor shaping the Swedish Life Sciences landscape is talent supply and retention. The sector is knowledge-intensive and increasingly dependent on specialised competences in areas such as biotechnology, data science and advanced manufacturing. Sweden faces growing international competition for qualified researchers, engineers and clinical specialists.

2. What three essential pieces of advice would you give to clients involved in Life Sciences?

First, adopt an integrated regulatory strategy and engage early. The proposed revision of the EU pharmaceutical legislation, the MDR/IVDR, the EHDS and related regulatory frameworks, create overlapping obligations that require a coherent approach across regulatory, IP, data protection, cyber resilience and commercial disciplines. Clients should actively prioritise resources where risks and overlaps are greatest, particularly around digital products and health data governance.

Second, treat compliance as core risk management rather than a standalone function. Compliance programmes should be regularly updated and commercial arrangements structured accordingly.

Third, beyond compliance, clients should invest in structural resilience by strengthening the protection of sensitive data and digital infrastructure in line with the requirements of the Swedish Cybersecurity Act (transposing the NIS2 Directive), as well as the Cyber Resilience Act. In parallel, clients should take active steps to mitigate single-point dependencies within their supply chains and reduce unnecessary exposure to geopolitical risk, with a view to ensuring operational continuity in the event of disruption.

3. What are the greatest threats and opportunities in Life Sciences Law in the next 12 months?

One of the most immediate threats is the erosion of incentive structures for R&D investment in Europe. Uncertainty surrounding an overly dynamic and regulation-intensive patchwork of rules that is difficult to navigate at the innovation stage, including regulatory data protection periods under the proposed pharmaceutical legislation revision, combined with declining domestic clinical trial activity, may undermine the commercial rationale for early-stage pipeline investment in small-market, high-R&D-intensity jurisdictions such as Sweden. Also, the impact of the US Most Favoured Nation (MFN) executive order is already materialising; data from the ten months following the order show a 35 per cent average decline in new pharmaceutical launches across Europe, with Sweden experiencing a 56 per cent decline. Swedish prices on new pharmaceuticals are nearly 18 per cent below the European average, and Sweden ranks 17th out of 22 comparable countries in spending on new medicines as a share of GDP (0.28 per cent), according to data from the Swedish Association of the Pharmaceutical Industry (LIF), TLV and EFPIA. These figures underscore the risk that a continued cost-minimisation approach may lead to further erosion of launch attractiveness, with cascading effects on the broader innovation ecosystem.

A second threat is the cumulative burden of overlapping regulatory reform. As example, the AI Act, the EHDS, the Cyber Resilience Act, the Data Act and the pharmaceutical package are each at different stages of adoption and implementation, with secondary legislation and guidance continuing to develop, creating a particularly challenging environment for SMEs that may lack the resources to navigate multiple concurrent compliance processes and face significant barriers to introducing new products on the market. Sweden’s national Life Sciences strategy has recognised the need for early dialogue with regulators and innovation-friendly procurement to support smaller companies in meeting regulatory requirements. The challenge lies less in any individual measure than in simultaneous implementation across multiple frameworks, requiring governance structures to be built under evolving conditions. Sweden’s lack of a coherent framework for secondary use of health data and geopolitical pressures on supply chains and talent further compound the difficulty.

A further immediate threat is cyber risk. Life Sciences companies operate highly digitalised environments with connected devices, sensitive clinical data and complex supply chains, making them particularly exposed to ransomware, data breaches and supply-chain attacks.

On the opportunity side, the EHDS, combined with Sweden’s strong assets in quality registries, biobanks and digital maturity, offers clear potential for clients that position early to leverage interoperable health data for research, real-world evidence and product development. Companies that build integrated AI governance stand to gain a meaningful first-mover advantage as enforcement timelines converge. In addition, the current funding environment creates openings for well-prepared buyers to identify scientifically strong but capital-constrained biotech assets and structure value-creating partnerships or acquisitions around them.

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

We ensure senior involvement and direct access throughout each engagement, so that the advice provided reflects both legal depth and a genuine understanding of the client’s commercial and scientific context. We continuously monitor the regulatory pipeline and provide targeted analysis of what specific developments mean for a client’s products, market position or contemplated transactions.

We staff engagements to cover the relevant intersections across regulatory, IP, data protection, AI, M&A and compliance, so that clients receive coordinated advice rather than separate inputs. Advice is structured around defined commercial questions.

Finally, we invest in understanding each client’s business model, strategy and risk appetite, enabling us to anticipate issues and align advice with management and board priorities.

5. What technological advancements are reshaping Life Sciences Law and how can clients benefit from them?

Several technological advancements are reshaping the Life Sciences legal landscape. AI is the most significant near-term driver; applications in medical devices, diagnostics and clinical decision support will in many cases qualify as high-risk under the AI Act, with demanding requirements for risk management, data quality, transparency and human oversight alongside the MDR/IVDR and the GDPR. Clients that build integrated governance across these regimes are better placed to deploy AI in regulatory workflows, pharmacovigilance and clinical solutions.

Access to large-scale computing infrastructure, including national resources such as NAISS, is becoming increasingly important for data-driven research and AI development within life sciences. Quantum computing is increasingly relevant for simulation-intensive areas such as molecular modelling and protein folding.

The forthcoming EHDS and national digital infrastructure initiatives, including the ongoing commission of inquiry into a national digital infrastructure for the healthcare system, will facilitate cross-border secondary use of health data, enabling clients to integrate real-world evidence into product development, market access strategies and health technology assessments. The pace and ambition of Sweden’s implementation will be a key factor in maintaining competitiveness. Clients that establish compliant data governance frameworks early will be well positioned to leverage decentralised clinical trials and large-scale registry-based studies as competitive advantages.

In precision medicine, evolving outcome-based reimbursement and risk-sharing models create openings in targeted therapies, companion diagnostics and biomarker-driven trials. The proposed Critical Medicines Act is reshaping supply chain strategies, while the green transition and Nordic cooperation offer further scope for cost reduction and competitiveness gains. Clients that proactively structure their contractual, regulatory and supply chain frameworks around these developments will be better positioned to access new reimbursement pathways and secure resilient supply chains as the regulatory environment evolves.