Welcome to this edition of Kromann Reumert's Life Science Update. In the following, we provide an overview of recent legal updates that will have a bearing on the life science industry across Europe, with particular focus on Denmark. This edition covers several significant developments, including the Council's position on the EU Pharmaceutical Reform Package.
EU
Council of the European Union adopts position on the Pharmaceutical Reform Package
On 4 June 2025, the Council of the European Union reached agreement on its position regarding the comprehensive reform of the EU’s pharmaceutical legislation. The Council emphasises that the aim is to create a fairer and more competitive EU pharmaceutical sector, marking the most significant modernisation of EU pharmaceutical rules in more than two decades. For a summary of the European Parliament's position, which was adopted in the spring of 2024, please see our April 2024 Life Science Update.
A central element of the reform, to which the EU institutions have taken different approaches, is the framework for regulatory data protection. The Council maintains the current 8-year regulatory baseline data protection for new medicines, rejecting the Commission’s proposed 6 years and the Parliament's proposed 7.5 years. During the data protection period, generic competitors cannot rely on originator data, meaning that access to these data is effectively restricted throughout this period. According to the Council's proposal, the data protection must be followed by a baseline market protection period of 1 year (which is 1 year less than the current 2-year market protection regime), in which period generic competitors may not place their products on the market, extendable by up to 2 years if certain predefined conditions are met. The Council has argued that the purpose of its proposed framework on this area is to ensure greater legal certainty for the industry.
For orphan medicinal products, the Council proposes 10 years of baseline market exclusivity (as the current regime, whereas both the Commission and the Parliament proposed 9 years), extendable by up to 2 years upon approval of new indications. The Council has, however, removed the separate market exclusivity period for products addressing high unmet medical needs, which had been proposed by both the Commission and the Parliament.
Another key focus is to improve access to medicines across the EU. Compared to the proposals from the Commission and the Parliament, the Council has adopted an intermediate position on this area. Under the Council’s mandate, a Member State may, within one year of the marketing authorisation, require the marketing authorisation holder to launch and supply the medicinal product in sufficient quantities in that Member State and to carry out specific actions in accordance with national law in relation thereto. Failure to comply within 4 years of the grant of the marketing authorisation results in loss of eligibility for any market protection or exclusivity period, as applicable.
To combat antimicrobial resistance, transferable exclusivity vouchers are introduced in the reform package to reward the development of breakthrough antimicrobials with an additional year of data protection. However, the Council has introduced several limitations compared to the Commission's and the Parliament's proposals: the total number of vouchers will be reduced from 10 to 5, vouchers may only be used in the 5th year of the data protection period, and only if annual gross EU sales have not exceeded EUR 490 million in any of the preceding 4 years.
The next step in the regulatory process is trilogue negotiations between the EU institutions which commenced on 17 June 2025 and is expected to continue until at least the end of 2025. Once the Council and the Parliament reach an agreement on the final text of the pharmaceutical reform package, it can be formally adopted.
The proposed legal acts can be accessed here and here. The Council’s press release is available here.
Updated EMA guidance on the publication of clinical data
In May 2025, the European Medicines Agency (EMA) published an updated version of its "External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use".
The revised guidance provides important clarifications to support pharmaceutical companies in complying with EMA’s transparency requirements, while ensuring protection of personal data through anonymisation and safeguarding of commercially confidential information. The guidance sets out practical procedures for submitting clinical reports and detailed instructions for anonymisation of clinical reports, and redaction of commercially confidential information.
Below is a summary of the key changes:
Summary of the key changes:
- Clarification of publication scope: All main studies are subject to publication under EMA’s transparency policy, even if follow-up phases are ongoing, provided the main part is completed at the time of submission.
- All report sections in scope: The full clinical study report is, by default, in scope for publication. Certain data-specific appendices remain out of scope. In addition, non-English documents will not be published and may be removed with a standard explanatory statement.
- Focus on anonymisation rather than deletion: Applicants may no longer remove entire case narratives from the reports. Instead, the reports need to be anonymised to be published, as EMA generally does not accept their omission or full redaction.
- Retention of adverse event data: EMA emphasises the need to preserve adverse event information in the published reports. Applicants must anonymise or generalise surrounding contextual information such as that found in case narratives, while retaining all adverse event data. Redactions are only allowed in exceptional cases – and then only if appropriately justified.
- Simplified document handling: Greater flexibility in how documents may be split or merged upon submission. These measures aim to address technical challenges and reduce administrative burdens but require prior approval from EMA through the LED process.
The updated version of the guidance is available here. A summary of the changes is available here
Denmark
One Contact Point for health data and clearer frameworks for secondary use
On 11 June 2025, the Danish Parliament adopted a bill introducing significant changes to the framework governing the secondary use of health data, access to information on dementia diagnoses, and the protection of healthcare professionals in cases concerning requests for access to documents. The bill forms part of the political vision for better use of health data and includes the following key elements:
- Establishment of the body One Contact Point (in Danish "Ét Kontaktpunkt"), which will serve as the primary entry point for applications seeking access to health data for research and innovation across the responsible public authorities. Requests concerning data held by a single data controller may be submitted directly to that controller. Data controllers are generally required to disclose requested data unless the workload significantly outweighs the recipient's interest.
- Introduction of new legal bases in the Danish Health Act supporting certain forms of secondary use of personal data (clinical trials, decision support in connection with patient treatment, and protection of patients' vital interests, e.g. in case of secondary findings).
- Amendment to the definition of "incident" in the Danish Scientific Ethical Committees Act (in Danish: "komitéloven") to include only adverse events related to activities described in the protocol. Reporting obligations for researchers are limited to serious incidents assessed or presumed to be related to the trial subject's involvement in the research project.
- Provision of a legal basis for the Danish Health Data Authority (in Danish "Sundhedsdatastyrelsen") to disclose information on dementia diagnoses to the Danish Patient Safety Authority (in Danish "Styrelsen for Patientsikkerhed") for the purpose of monitoring doctors' prescription of antipsychotic medicines to patients with dementia.
- Introduction of limitations on access to names of healthcare personnel or others mentioned in patient records if significant considerations for the individuals' safety justify such limitations.
The bill as adopted is available here (in Danish).
Spring Agreement paves the way for implementation of the healthcare reform
The Danish Government, Danish Regions and Local Government Denmark (KL) have taken the first formal step towards implementing the healthcare reform by entering into the Spring Agreement of May 2025. The agreement marks the beginning of the efforts to establish a more coherent and locally anchored healthcare system for patients in Denmark.
A key element is the redistribution of healthcare responsibilities between municipalities and regions. The parties have agreed to transfer a number of core tasks from the municipalities to the regions, including acute nursing care, temporary healthcare and care facilities, specialised rehabilitation, and patient-targeted preventive care. Accordingly, the regions will assume a broader treatment responsibility. Additionally, hospitals’ post-charge treatment responsibility will be extended from the current 72 hours to 96 hours.
To support the redistribution, the reform introduces new governance models and cooperation forums, including the establishment of 17 local health councils (in Danish: "sundhedsråd") composed of political representatives from both the regional and the municipal councils.
The regions will be granted new powers and funding to ensure the presence of more general practitioners in areas with shortage. This will be achieved through new clinic models (such as tendered clinics and regional clinics) and a national allocation model for general practitioner capacity.
The agreement aims to strengthen the locally anchored healthcare system through investments in local treatment services and facilities. Funding will enhance the physical infrastructure, allowing more treatment options outside hospitals and closer to the citizens. New local hospitals (in Danish: "nærhospitaler") and healthcare centres (in Danish: "sundhedshuse") may be established, integrating regional and municipal services. The goal is to create more coherent patient pathways and ensure that more citizens receive treatment and follow-up services locally rather than in hospitals.
The Spring Agreement can be accessed here. Additionally, the Ministry of the Interior and Health has issued a press release regarding the agreement, which can be accessed here.
Strengthening of the Danish Medicines Council’s role in the future
In May 2025, the Danish Medicines Council launched its new strategy for 2025–2027 under the headline “Towards a Sustainable Healthcare System” (in Danish: "Mod et bæredygtigt sundhedsvæsen"). The strategy addresses the increasingly complex and costly medicines, rising patient expectations, and healthcare system pressures.
The strategy focuses on ensuring timely and equitable access to effective medicines without overburdening resources. The Council’s Chair, Birgitte Klindt Poulsen, emphasizes that while opportunities and complexity in medicinal treatment continue to grow, financial and capacity constraints persist. Accordingly, the Council will focus on its core mandate: assessing and prioritising medicinal products.
Applications for new medicines increased by approximately 60% from 2023 to 2024. Many of them are advanced, costly, and associated with uncertainties regarding their real-world effectiveness. At the same time, more patients will in the future be treated outside hospitals, necessitating improved cross-sectoral collaboration. The strategy reflects these needs by emphasising that the Council must continue to deliver timely and thorough assessments of new medicines while clearly explaining how and why certain treatments are prioritised. This requires professionalism, transparency and openness in methodologies and decision-making.
The strategy sets out three key focus areas:
- Timely and effective medicine assessments for the benefit of patients
- Clear prioritisation of adopted products
- Stronger stakeholder dialogue and transparency
Developed in dialogue with key stakeholders, including industry representatives, the hospital sector and public authorities, the strategy reflects a shared ambition to ensure a healthcare system capable of meeting future challenges.
Overall, the new strategy marks a renewed emphasis on professionalism and transparency in medicinal assessments, combined with a more collaborative approach.
A general presentation of the strategy is available here (in Danish). The full strategy is available here (in Danish).
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