European Health Care News – April 2025

The Strategy aims to support Member States and enhance Europe’s capability to prevent and respond to emerging threats. The action plan includes the development of minimum preparedness criteria for essential services such as hospitals; the strengthening of civil-military cooperation through preparedness exercises involving health care workers as well; and a Union prevention, preparedness and response plan for health crises (EN/FR/NL).

The European Commission published a report assessing the work and functioning of the Health Emergency Preparedness and Response Authority (HERA) since its establishment in 2021. The report acknowledges the contribution that HERA made in reinforcing EU’s ability to prepare and respond to crises; it also highlights areas for further improvement (EN/FR/NL).

The European Commission presented the state of the implementation of Europe’s Beating Cancer Plan from its launch in 2021 to the end of 2024, and assessed whether additional action is needed (EN). The review is based on a study mapping and evaluating the implementation of the Plan (EN), as well as on evidence gathered from all relevant Commission departments involved in its implementation.

The European Commission published the second edition of the Country Cancer Profiles, which assess the main achievements, challenges and disparities in cancer prevention and care in the 27 Member States of the European Union (EU), Iceland and Norway. A synthesis report summarises and compares the situation at EU level (EN/FR/NL).

The new report from the Expert Group on Health System Performance Assessment (HSPA) provides a comprehensive definition of low-value care, examines how it can be measured in the context of HSPA, and identifies measures and policies to reduce its use (EN).

In addition to the new Committee on Public Health, whose members have now been appointed (EN/FR/NL), two intergroups will deal with specific health issues during the 2024-2029 term. One focuses on cancer and rare diseases (EN/FR/NL); the other focuses on mental health (EN/FR/NL). Although they are not official parliamentary bodies, the intergroups serve as a platform for exchanging views and keeping specific issues on the agenda across different sectors. An interest group on health inequalities, prevention and risk factors was also launched (EN).

The proposed regulation aims to support supply chain diversification, boost pharmaceutical manufacturing in the EU and facilitate joint procurement among Member States. While the focus is on the products included in the Union list of critical medicines, other medicines of common interest are also targeted, such as medicines for rare diseases and novel antimicrobials (EN/FR/NL). The proposal was informed by the strategic report recently released by the Critical Medicines Alliance (EN).

Belgium and nine other Member States urged the European Commission to fully consider the recommendations made by the Critical Medicines Alliance, including developing a list of industrially vulnerable medicines and enabling a coordinated, specific investment plan (EN). To support investments, the health ministers from Belgium and ten other Member States also proposed integrating the Critical Medicines Act into the EU defense and security strategy (EN, FR).

The European Commission adopted the procedural rules for conducting joint scientific consultations on medical devices and in vitro diagnostic medical devices (EN). They are part of the fifth implementing act adopted under the Regulation on Health Technology Assessment (HTA), which became applicable on 12 January 2025 (EN/FR/NL).

Now that the HTA Regulation has become fully applicable (EN/FR/NL), a framework contract was signed between the European Health and Digital Executive Agency (HaDEA) and a consortium of HTA bodies representing 21 Member States (EN). Led by the Belgian National Institute for Health and Disability Insurance (NIHDI), the consortium will jointly assess new medicines coming on the market (EN/FR/NL).

The new list defines hazardous medicinal products that can cause unintended effects in workers who are exposed to them in the workplace in sectors such as health care and veterinary care. The aim of the European Commission is not to replace these medicines, but to improve the quality of their risk assessment and to provide an EU-level approach in addressing carcinogens, mutagens and reprotoxic substances (EN/FR/NL).

The European Commission published an EU action plan focused on the cybersecurity of hospitals and health care providers. Given their interdependence with other health entities, the proposed measures also address risks affecting the wider supply chain and ecosystem. Four priorities are targeted: improved prevention, better detection of cyber threats, rapid response and recovery, and enhanced deterrence (EN/FR/NL).

The draft Council Recommendation proposed by the European Commission updates the EU framework for cybersecurity crisis management. It maps the relevant actors and their role throughout the crisis lifecycle. Although non-binding, the blueprint is expected to strengthen coordination, leverage existing instruments and support collective cyber resilience in critical sectors such as health (EN). The EU ministers responsible for cybersecurity called for a timely adoption of this EU Blueprint at the informal meeting held on 5 March under the Polish Presidency of the Council (EN).

The initiative aims to address skills gaps and labour shortages and thereby increase the EU’s competitiveness by supporting the development of quality, inclusive and adaptable education, training and skills systems. Four main strands are targeted: building skills for quality jobs and lives; upskilling and reskilling the workforce; circulating skills across the EU; attracting, developing and retaining talent. The health care sector is also concerned by the measures proposed (EN/FR/NL).

The roadmap published by the European Commission sets out a long-term political vision to uphold and advance key principles of women’s rights and gender equality. To ensure the right of every woman to the highest standards of physical and mental health, the Commission’s commitments include supporting and complementing Member States’ action on women’s access to sexual and reproductive health and rights, and promoting gender-sensitive medical research, clinical trials, diagnostics and treatments (EN/FR/NL).

The Compass provides a strategic framework to guide the Commission’s work to boost EU competitiveness for the period 2024-2029. It links flagship measures with the aim of making progress in three core areas (innovation, decarbonisation and security) and supporting horizontal enablers for competitiveness. The Compass is also relevant to the health sector as it touches on research, artificial intelligence and biotechnology, preparedness and critical medicines, EU funding and labour policies (EN/FR/NL).

The European Commission presented the key policy and budgetary challenges that will shape the design of the next Multiannual Financial Framework, starting in 2028. It announced that current budget programmes will be divided into three funds: national plans with key reforms and investments; a European Competitiveness Fund; and a revised funding for external action (EN/FR/NL). This will also affect programmes that now support investment and reform in the health sector, according to a leaked document outlining the architecture of the new long-term budget (EN).

Concerns were raised about the possibility of merging the European Social Fund Plus (ESF+) with other funds in the context of the Multiannual Financial Framework starting in 2028. The European Parliament called for a strong, reinforced and separate ESF+ post-2027 by stressing the need to support social investment and ensure universal access to quality public services, including health care (EN/FR/NL). Several pan-European associations also called for a standalone ESF+ to ensure that the EU social priorities are safeguarded (EN).

Against the possibility of merging Horizon Europe in the next Multiannual Financial Framework, calls were made for the upcoming framework programme for research and innovation to be independent and adequately funded. By endorsing the Warsaw Declaration, the research ministers of all 27 Member States underlined the key role of the programme in supporting research and innovation in the EU and recalled that it is enshrined in the EU Treaties (EN). The European Parliament also called for a programme with broad long-term policy ambitions (EN/FR/NL). Today, cluster 1 of the second pillar of Horizon Europe is specifically dedicated to health research.

The European Commission launched InvestAI, an initiative aimed at mobilising investment in artificial intelligence (AI). This includes a specific fund for AI gigafactories, which will enable open, collaborative development of most complex AI models in the EU. Health care is one of the sectors where improvements are expected thanks to the introduction of AI (EN/FR/NL).

The first project is JADE Health, a joint action addressing dementia and health that is led by Spain and involves 15 Member States, Norway and Ukraine (EN). The second project is JARED, a joint action on respiratory disease led by Hungary and involving 14 Member States, Iceland, Ukraine and Moldova (EN). The third is JANE-2, the second joint action on the EU networks of expertise on cancer, which is coordinated by Italy and brings together 121 partners from 29 European countries (EN). The last is a partnership between the European Commission and UNICEF aiming to improve the mental and physical health of children in EU Member States, Iceland and Norway (EN).

The European Commission has approved the acquisition of exclusive control over Opella Healthcare SAS (from France) by Clayton, Dubilier & Rice, LLC (United States). This approval covers Opella’s activities in research, development, manufacturing, and commercialisation of over-the-counter medicinal products available without a prescription. The Commission stated that the acquisition does not raise competition concerns, as the companies’ market position remains limited following the transaction (EN).

The European Commission has approved the acquisition of exclusive control over the ‘Pharmaceutical Solutions’ division of International Flavors and Fragrances Inc. (IFF, from the United States) by Roquettes Frères S.A. (France). The acquisition primarily concerns the development, production, and sale of pharmaceutical excipients. The Commission stated that the acquisition does not raise competition concerns due to its limited impact on competition in the markets where the companies operate (EN).

The European Commission has approved the acquisition of joint control of Matrix Topco Limited (Biocomposites – from the UK) by Novo Holdings A/S (Denmark) and TA Associates Management L.P. (United States). The acquisition concerns Biocomposites’ activities in the development of calcium compounds and specialized polymer products for surgical use. Following its assessment, the Commission concluded that the joint venture would not raise competition concerns, as it has negligible activities in the European Economic Area (EN).

The European Commission has approved the acquisition of joint control of OMH HealthEdge Holdings, Inc. (Omega Healthcare – from the United States), by Goldman Sachs Group, Inc. (United States) and the Ontario Teachers’ Pension Plan Board (OTPP) of Canada. The transaction relates to the market for revenue cycle management services provided for US health care organisations. After conducting its assessment, the Commission determined that the acquisition does not raise competition concerns, as its impact on the European Economic Area is limited (EN).

The European Commission has granted approval for the acquisition of sole control of Hellenic Healthcare S.à.r.l. (from Luxembourg) by Pure Health Holding PJSC (United Arab Emirates). This transaction concerns the health care sector in Greece and Cyprus. Following its assessment, the Commission concluded that the acquisition would not raise competition concerns, as the companies involved do not operate in the same market or in vertically related sectors (EN).

In Joined Cases C‑119/22 and C‑149/22, the Court addressed the requests for a preliminary ruling from the Market Court of Finland and from the Supreme Court of Ireland, concerning the validity of supplementary protection certificates (SPC) granted to pharmaceutical products intended for the treatment of diabetes and cholesterol. The Court ruled that Regulation (EC) N° 469/2009 concerning the SPC for medicinal product must be interpreted so that an SPC can be granted for a product containing two active ingredients, even if one of them was previously the subject of an SPC and was the only one disclosed in the basic patent, while the other was already known at the patent’s filing or priority date. Moreover, it is to be interpreted that a product consisting of two active ingredients is protected by a basic patent as long as their combination falls under the invention covered by the same patent (EN/FR/NL).

In Case C-586/23 P, an appeal was filed to annul the General Court’s order of 27 July 2023. The General Court had dismissed a previous appeal seeking to annul two Commission decisions implementing marketing authorization for Spikevax – elasomeran, and for the Comirnaty – tozinameran, both Covid-19 vaccines. The new appeal was dismissed in its entirety (EN/FR/NL).

Advocating for greater transparency in negotiations with vaccine manufacturers for the purchase of Covid-19 vaccines, individuals appealed to the General Court of the European Union, which partially ruled in their favour, in particular with regard to the Commission’s refusal to disclose the identity of members of the negotiating team by providing anonymized versions of the declarations of absence of conflict of interest. The Commission appealed to have the judgment set aside and requested interim measures to delay the execution of the judgment. In Case C-632/24 P-R, the Vice-President of the Court of Justice accepted the Commission’s request to suspend the enforcement of part of the General Court’s judgment. This suspension remains in place until the appeal proceedings are concluded (EN, FR, NL).

In Case C-517/23, the German Federal Court of Justice requested a preliminary ruling from the Court of Justice of the European Union. The company DocMorris, which has been running advertising campaigns in Germany to promote the purchase of prescription-only medicines, claims it suffered damage since the Professional Association of Pharmacists of the North Rhine region obtained unjustified interim measures from a German Court to stop its advertising campaigns, later annulled. The Court ruled that Directive 2001/83/EC on the Community code relating to medicinal products does not cover advertising that promotes price reductions, payments of an exact amount, or unspecified rewards for purchasing unspecified prescription-only medicinal products. However, Member States may restrict advertising that offers unspecified rewards on consumer protection grounds. For vouchers used to purchase non-prescription medicines or health and care products, national laws can prohibit such advertising measures (EN, FR, NL).

In case C-715/23, the Slovenian State Public Procurement Tribunal has requested a preliminary ruling on the interpretation of Directive 2014/23/EU regarding the award of concession contracts, to determine whether pharmacy operation services qualify as an economic activity under that Directive and thus if EU public procurement rules apply. The Advocate General, in his Opinion on the interpretation of Article 4(2), stated that pharmaceutical services cannot be classified as ‘non-economic services of general interest’ when their main purpose is to supply users with prescription and non-prescription medicines for human use, along with advice. Article 19 on ‘social and other specific services’ confirms that such pharmaceutical services fall within its scope, meaning they are subject to simplified procedures for the awarding of concession contracts (EN/FR/NL).

In the appeal C‑2/24 P, Teva Pharmaceutical Industries and Cephalon request that the judgment of the General Court of the European Union (T‑74/21), which rejected their application, be set aside. Their application primarily sought to annul the European Commission’s decision which found that the appellants restricted competition both by object and by effect by entering into a settlement agreement to resolve patent litigation. This case provides the Court with an opportunity to clarify the criteria for determining a restriction of competition in a patent settlement agreement between an originator medicine manufacturer holding secondary patents and a generic drug manufacturer. The Advocate General’s Opinion recommends that the Court dismiss the appeal (EN/FR/NL).

The European Commission has sent a letter of formal notice to seven Member States (Belgium, Bulgaria, Greece, Lithuania, Portugal, Romania and Spain) for failing to communicate the transposition of Directive 2022/542. This Directive allows Member States to apply reduced VAT rates to essential products such as pharmaceuticals and medical-use products (EN/FR).

The European Commission has issued a reasoned opinion to Romania for failing to comply with Directive 2011/7/EU on combating late payment in commercial transactions. The Romanian public health insurance entity has been late in paying independent Romanian pharmacies for medicines provided to patients under the national health insurance system. This delay can potentially push pharmacies into bankruptcy and disrupt the entire supply chain (EN/FR/NL).

An article by Irinia Kessissoglou and colleagues published in the ‘European Journal of Public Health’ presents the results of a 2022 country mapping study on health data management systems across 12 EU Member States, including Belgium. The study assessed their preparedness to comply with the European Health Data Space (EHDS) regulation. The findings indicate a need for improved digitalisation and data quality. The main conclusion is that none of the examined Member States are fully prepared to comply with the EHDS provisions. However, there is a political will to align health data management systems with the new regulation (EN).

A viewpoint by Amandine Garde and colleagues published in the ‘Lancet Regional Health – Europe’ highlights the stagnation in the European Commission’s efforts to introduce new legislation on food and alcohol labelling under the Prevention Pillar of Europe’s Beating Cancer Plan. This paralysis is attributed to a lack of transparency and openness, which are essential for ensuring policy actors’ accountability through citizen participation in the legislative process (EN).

The Eurofound report on quality of life in the EU in 2024, based on the Living and Working in the EU e-survey, identifies the main post-pandemic concerns of European citizens. They include unmet medical needs: people aged 50-64 face difficulties accessing hospitals and specialist services; low-income households identify health care costs as a major barrier; and younger respondents report unmet mental health service needs, contributing to declining mental well-being across the EU (EN). The analysis also shows that respondents with disability are more likely to experience unmet medical needs (EN).

The EU4Health Civil Society Alliance expressed concerns over recent limitations on civil society activities. They called on the EU to reconsider the restrictions on LIFE Programme funding dedicated to policy and advocacy activities. This change adds to the uncertainty faced by health-focused civil society organisations, and the alliance also asked for greater transparency and a clear timeline in publishing the EU4Health 2025 Work Programme (EN).

In an opinion piece, Sander Tordoir from the Centre for European Reform emphasizes the need for the EU to prioritize public health investment under its new fiscal rules and post-2027 budget. He states that while public health was a central political priority during the Covid-19 pandemic, its importance has since declined rapidly. Furthermore, he argues that ensuring the productivity of a shrinking workforce is crucial for sustaining economic growth, as it improves health outcomes and leads to other socio-economic advantages (EN).

The symposium ‘Health: The Underestimated Engine of the Economy’ was held on 5 February at the Permanent Representation of France to the EU. It focused on the economic and strategic challenges in the health care sector and the pharmaceutical industry in Europe, considered two key pillars of the EU economy. Experts proposed several measures to enhance the competitiveness and resilience of these sectors, including simplifying the regulatory framework, emphasizing the importance of health promotion, and increasing investments in prevention (EN/FR).

The latest report from the Pharmaceutical Group of the European Union (PGEU) highlights the persistent issue of medicine shortages across Europe in 2024. Shortage levels remain high, and a concerning trend has emerged: pharmacists are spending an increasing amount of time managing these shortages, now averaging 11 hours per week (EN).

An article by Christian Freudlsperger in the ‘Journal of European Public Policy’ examines the EU’s evolution in response to crises like Covid-19 and the Euro crisis. He argues that the EU is increasingly becoming a reinsurance polity, where Member States remain the primary insurers of their citizens, but the EU provides backup support when national capacities are overstretched. HERA (the Health Emergency and Preparedness Response Authority) exemplifies this approach, demonstrating how the EU extends beyond a regulatory role without fully evolving into positive state-building (EN).