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1. Major SPC reform: is Europe's intellectual property (IP) landscape about to change?
Significant reforms to supplementary protection certificates (SPCs) may be imminent following the European Parliament's adoption of major changes in 2024. The cornerstone of the reforms to Europe’s patent term extension is centralising SPC examination at the European Union Intellectual Property Office (EUIPO) for European patents with centralised marketing authorisations. The unitary supplementary certificate for medicinal products would complement the unitary patent replacing the current system of filing through individual national patent offices. This new process would have EUIPO examine and issue opinions on SPC applications, while allowing stakeholders to participate through third-party observations and opposition procedures.
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2. Clinical trials’ transition to new EU system: three-year transition period ends
As the three-year implementation period concludes, the EU Clinical Trials Regulation requires all ongoing clinical trials to move to the Clinical Trials Information System (CTIS). Sponsors must plan for the transition, considering evaluation procedures that could take up to three months, with some expedited options available. On 3 February 2025, the Netherlands' Central Committee on Research Involving Human Subjects (CCMO) introduced its Research Portal, streamlining submissions for medical research in the Netherlands. This initiative demonstrates the EU's commitment to modernise clinical trial oversight while maintaining research continuity.
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3. The EU AI Act and EHDS regulation set high standards for AI literacy, risk management, data governance, interoperability, and patient consent
As of 2 February 2025, the EU Artificial Intelligence Act’s enforces provisions such as AI literacy and ban systems with unacceptable risks, including biometric categorisation, and untargeted facial image scrapping to create or supplement facial recognition databases. By 2 August 2025, additional rules will come on notified bodies, GPAI models, governance confidentiality, and penalties will come into effect.
AI deployment in healthcare and life sciences is accelerating, with AI agents making (semi-)autonomous decisions based on their environment and objectives. They forecast demand for medicinal products, manage inventory, ensure timely distribution of medical products, and monitor trials in real-time, significantly impacting patient care and medical decision-making. As these systems evolve, handling sensitive health data safely is essential. Robust governance measures ensure compliance with the AI Act, including, transparency, risk management, and model evaluations.
In 2025, the EU will adopt the regulation on the European Health Data Space (EHDS), crucial for digitising and utilising health data. The EHDS establishes a legal framework for accessing and exchanging electronic health data, enabling uses without prior patient consent but offering individuals the option to opt out. While the EHDS gives access to a broader pool of health data and sets requirements for data governance, interoperability, and patient consent management.
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4. Dutch law requires correct classification of employment relationships
Starting 2025, Dutch tax authorities enforce the proper classification of employment relationships under the Assessment of Employment Relationships (Deregulation) Act (Wet DBA). They assess whether work performed under a services agreement has been incorrectly classified as self-employment. Although no fines will be imposed in 2025, standard fines will apply from 2026 onwards. Dutch employers must analyse their relationships with self-employed personnel to ensure compliance with Dutch wage tax and social security laws, avoiding fines and additional tax assessments.
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5. Deal makers should carefully consider regulatory merger control and foreign direct investment factors
In 2020, the EU introduced a regulation to screen foreign direct investments. The EU FDI Regulation arranges the cooperation between allows EU member states and the European Commission on investment screening. Currently, a The European Parliament is discussing reshaping this regulation, though its timing and impact on the Benelux FDI regimes remain unclear. Businesses and investors entering or expanding in the EU market must stay aware of the changing regulatory environment, especially regarding investments in critical infrastructure, sensitive technology and other areas that are important to the EU's economic security.
Want to know more?
At NautaDutilh, we know that navigating new regulations can be complex. Our team can help your organisation meet all requirements. For personalised assistance, please contact one of our experts.
