European Health Care News - September 2026

A new report provides insights into how staffing levels in health care are defined, implemented, utilised and evaluated across the Member States of the European Union (UE) and Norway. This mapping of the various approaches and methods used to address staffing levels aims to facilitate mutual learning and identify best practices. It was prepared by the European Commission’s Expert Group on Health Systems Performance Assessment (HSPA), with support from the European Observatory on Health Systems and Policies (EN).

The Council of the EU and the European Parliament have reached a provisional agreement on a new regulation tackling shortages of critical medicines and medicines of common interest, such as antibiotics, insulin and painkillers. The agreement expands the scope of the act to include orphan medicinal products in the implementation of strategic projects and collaborative procurement (EN/FR/NL).

The European Commission has published uniform requirements for the conformity assessment activities carried out by notified bodies under EU regulations on medical devices and in vitro diagnostic medical devices (EN/FR/NL). Two delegated acts have also expanded the list of well-established technologies under the Medical Devices Regulation that can be exempted from the obligation to perform clinical investigations or to assess the technical documentation of each device (EN/FR/NL, EN/FR/NL).

From the second quarter of 2026, the European Medicines Agency (EMA) will provide enhanced regulatory support and priority scientific advice to manufacturers of designated breakthrough medical devices and in vitro diagnostics. The pilot programme will inform a potential future framework for breakthrough medical devices, which the European Commission included in its December 2025 proposal to revise the regulations on medical devices and in vitro diagnostic medical devices (EN).

From April 2026, a panel of high-level experts will meet quarterly to advise the European Medicines Agency (EMA) on issues related to vaccine hesitancy. The panel will help to identify and address public concerns that could undermine public trust in vaccines. They will also collaborate with health care professionals and develop communication materials and awareness campaigns on vaccines (EN).

The European Commission presented 22 actions aiming to ensure the gradual transition to innovative non-animal approaches for chemical safety assessments in 15 domains, including chemical pharmaceuticals. The roadmap also sets out indicators to monitor progress in their implementation (EN/FR).

A resolution from the European Parliament calls for sufficient flexibility and proportionate measures to ensure that the revised Urban Wastewater Treatment Directive does not compromise the affordability, availability or accessibility of medicines. The Directive entered into force on 1 January 2025 and applies the “polluter pays principle” to manufacturers of medicinal products. The resolution calls for the temporary suspension of its provisions until the completion of a new impact assessment from the European Commission. The text was adopted by 294 members (EN).

The European Commission has published its fourth State of the Digital Decade report. It shows progress made towards achieving the 2030 digital transformation targets, as well as the gaps that remain. It also makes recommendations to the EU and its Member States, urging funding continuity beyond 2026. The core report is supplemented by 27 country reports, staff working documents, and study reports. One of these focuses on the eHealth target of ensuring that all EU citizens have access to their electronic health records by 2030 (EN/FR/NL, EN).

The Council of the EU and the European Parliament reached a provisional agreement on amending regulations 883/2004 and 987/2009, governing the coordination of social security systems. Proposed by the European Commission in December 2016, the revision aims to clarify, simplify and improve the enforceability of the existing rules. The amendments focus on five areas, including long-term care benefits, access to benefits for economically inactive persons, and the legislation applicable to individuals working in two or more Member States (EN/FR/NL). The provisional agreement was endorsed by Member-State ambassadors to the EU in April (EN/FR/NL) and by the Parliament in July (EN/FR/NL).

The European Commission has published the EU anti-poverty strategy. It acknowledges the key role of social services in guiding vulnerable people towards the services they need, such as health care. The strategy also highlights the importance of ensuring access to long-term care services for the most vulnerable, and announces the publication of a European Care Deal in 2027 (EN/FR/NL).

One of the new initiatives listed in the EU anti-poverty strategy is the proposal for a Council recommendation on housing. This acknowledges that housing is a key social determinant of health and social inclusion. Member States are recommended to adopt person-centred and integrated policies that support sustainable, affordable, quality housing, while also ensuring access to key services such as health care (EN).

As part of the EU anti-poverty strategy, the European Commission published a communication proposing new measures to strengthen the implementation of the European Child Guarantee. Adopted in 2021, the Guarantee aims to prevent and combat social exclusion by ensuring that children in need have effective access to key services, such as health care. The new measures for the health sector focus on children’s well-being and mental health. From 2027, a new digital framework for a European Child Guarantee Card will also be tested (EN, EN).

The European Commission analysed the social convergence challenges existing in Bulgaria, Greece, Spain, Italy, Latvia, Lithuania, Luxembourg, Romania and Finland. These nine Member States were flagged in the 2026 Joint Employment Report as facing potential risks to upward social convergence. This second-stage analysis takes a closer look at the challenges faced, their causes and impacts, and assesses policies implemented or planned to address them. Health care and long-term care are among the sectors explored. The findings are intended to inform the 2026 European Semester Spring Package (EN).

As part of the 2026 European Semester Spring Package, the European Commission has proposed a Council decision that updates the guidelines for the employment policies of the Member States. These guidelines cover new elements aimed at improving job quality and investing in human capital. In particular, guideline 8 invites Member States to foster social inclusion and prevent and fight poverty, including by modernising their social protection systems and ensuring timely access to affordable preventive and curative health care (EN, EN/FR/NL).

The Council of the EU and the European Parliament reached a provisional agreement on the sixth revision of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work. While the Parliament wanted to include a definition of hazardous medicinal products (HMPs) and add ‘work involving HMPs’ to the list of substances, mixtures and processes set out in Annex I of the directive, the final compromise includes two recitals that clarify that HMPs containing carcinogens, mutagens or reprotoxic substances fall within the scope of the directive, and recall the existing provision regarding training for workers (EN/FR/NL).

The European Parliament has adopted a resolution to address gender inequalities in formal and informal care. It calls for a ‘European carers’ statute to recognise care work and set minimum standards across the EU, including regarding pensions and social security benefits. It also calls on the European Commission and the Member States to align the EU health strategy and the EU care strategy and foster synergies between EU4health and other financing mechanisms for the care sector in order to better connect health care and social care systems (EN/FR, EN/FR/NL).

The European Commission has adopted the 2026 European Semester Spring Package (EN/FR/NL). This includes country reports that analyse economic, social, and employment developments, and assess the extent to which Member States have implemented the country-specific recommendations adopted in 2025. The thematic annex dedicated to ‘health and health systems’ shows progress made in this area together with the ongoing challenges. Improving access to and affordability of health care and long-term care remains a priority in several countries, but cost effectiveness and fiscal sustainability need to be considered. This requires tackling workforce shortages and territorial disparities in several Member States (EN).

The 2026 Spring Package that the European Commission has published as part of the European Semester cycle includes targeted recommendations to Member States, designed to guide them in addressing the economic and social challenges identified in the country reports. Country-specific recommendations related to health care have been addressed to 16 Member States, ranging from access to and affordability of health care, primary health care and prevention, to recommendations on the health care workforce and, in some cases, cost-efficiency and fiscal sustainability (EN, EN).

As part of the 2026 European Semester Spring Package, 21 Member States received a country-specific recommendation related to long-term care. In line with recommendations from previous years, Belgium was called to make its long-term care system more cost-effective. Cost-efficiency and fiscal sustainability were recommended to a few other countries, while most of the recommendations focused on improving access to affordable and quality long-term care services (EN).

The European Commission has opened several calls under the Digital Europe Programme. Two of them specifically aim to support artificial intelligence (AI) in health. The first supports the introduction of AI-powered image screening in medical centres, while the second supports digital health services and systems under the European Health Data Space (EN).

The European Court of Auditors audited whether the European Commission and the Member States ensured sufficient traceability and transparency of funds received under the Recovery and Resilience Facility (RRF) to support measures, reforms and investment in several sectors, including health. It highlighted remaining gaps and recommended that future instruments provide for systematic collection, use, and publication of all relevant data on the use of EU funds (EN/FR/NL).

A cross-party group of 70 Members of the European Parliament sent a letter to the European Commission urging the immediate reinstatement of operating grants for health civil society organisations funded under the EU4Health 2026 Work Programme. The letter highlights the severe impact that the removal of this structural funding has already had on health organisations and calls for a more transparent and inclusive process in shaping EU health funding priorities (EN).

The European Commission has opened an antitrust investigation into Align Technology, a global medical device company headquartered in the United States. The Commission wants to assess whether the company has breached EU competition rules by tying its intra-oral scanners to its dental clear aligners branded as Invisalign in the European Economic Area (EN/FR).

The European Commission has opened a formal antitrust investigation to assess whether the multinational company Sanofi has breached EU competition rules. The European Commission is particularly concerned that Sanofi ran a misleading communication campaign aimed at health care professionals in Germany and France that disparaged the only rival flu vaccine recommended for people over 60. This vaccine is marketed by the company CSL Seqirus under the brand name Fluad (EN/FR).

The European Commission has approved the acquisition of joint control of the American company Teleflex OEM Business by two private equity firms: Kohlberg & Co, also based in the United States, and Montagu Private Equity from the United Kingdom. The transaction relates primarily to the medical device industry (EN).

The European Commission has approved the acquisition of joint control of Tecomet and Orchid by Charlesbank Capital Partners, all based in the United States, and Nordic Capital from Jersey. The transaction relates primarily to contract manufacturing services for orthopaedic implants and instruments (EN).

The European Commission has approved the acquisition of joint control of Rayner Surgical Group, based in the United Kingdom, by Groupe Bruxelles Lambert, a publicly listed investment holding company headquartered in Belgium, and CVC Capital Partners from Jersey. The transaction relates primarily to the manufacturing and supply of ophthalmic surgical products (EN).

The European Commission has approved the acquisition of sole control of Lonza’s capsule and health ingredients business, based in Belgium, Switzerland and the United States by the private equity firm Lone Star Funds from Bermuda. The transaction relates primarily to capsules for the pharmaceutical and nutraceutical industries (EN).

In case C-131/25, the Advocate General took the view that national legislation which does not treat students who have completed all or most of their secondary education in Belgium, whilst being resident in another Member State, in the same way as residents in Belgium is contrary to EU law. In particular, such legislation cannot restrict their first-time enrolment in medical sciences courses at higher education institutions (EN/FR/NL, EN, FR).

In Case C-631/24 P, the Advocate General proposed that the Court of Justice reject the European Commission’s appeals against two General Court rulings of July 2024. In doing so, he reaffirmed that the European Commission did not grant the public sufficiently broad access to agreements for the purchase of COVID-19 vaccines (EN/FR, EN, FR).

In Case C-522-24, the Court of Justice ruled that compulsory vaccination against SARS-Cov-2, limited to military personnel of the Ministry of Defence, to the exclusion of civilian personnel, does not constitute discrimination under EU law. In addition, Directive 2000/78/EC establishing a general framework for equal treatment in employment and occupation does not preclude compulsory vaccination of a member of the military personnel who objects to such vaccination based on opinions on public health policy rather than on personal beliefs (EN/FR/NL, EN, FR).

The European Commission has referred Bulgaria, France, Luxembourg, the Netherlands, Poland, Spain and Sweden to the Court of Justice of the European Union for failing to transpose Directive (EU) 2022/2557 on the resilience of critical entities into their national legislation. The directive aims to ensure the continued provision of services vital for EU society and economy in key sectors, including health (EN/FR/NL).

The European Commission has sent letters of formal notice to Austria, Croatia, Cyprus, Denmark, Germany, Greece, Malta and Portugal for failing to notify the measures that fully incorporate into national law Directive 2024/782 amending Directive 2005/36/EC on the recognition of professional qualifications. The amendments update the minimum training requirements for nurses responsible for general care, dental practitioners and pharmacists (EN/FR).

The European Commission has referred France to the Court of Justice of the European Union as its national rules governing veterinary companies and veterinarians fail to comply with EU rules on the freedom of establishment and the free movement of services, as set out in the Treaty on the Functioning of the European Union and Directive 2006/123/EC on services in the internal market (EN/FR/NL).

The European Commission reaffirmed its commitment to supporting the implementation of the EU Disability Strategy for 2021-2030, which aims to improve accessibility and inclusion for persons with disabilities. This includes helping Member States improve access to physical and mental health care, as well as sexual and reproductive health and rights, for persons with disabilities (EN/FR/NL).

The European Commission has adopted two complementary strategies that address the specific needs of people living in EU islands and coastal areas. The aim is to establish a coherent and holistic framework within existing policies and funding to strengthen economic opportunities, improve quality of life, and increase resilience. Both strategies recognise the importance of investment to ensure access to key services, such as health care (EN/FR/NL).

The European Commission has adopted a Global Health Resilience Initiative, which aims to scale up global prevention, preparedness and response to future health threats. The initiative focuses on five areas: enhanced coordination on global health; strengthening the health systems of partner countries; reinforcing prevention, preparedness and response capacity through global networks, the availability of medical countermeasures and tracking tools; diversifying global supply chains and the manufacturing of key health products; and fostering trust in science (EN/FR).

In an article published in the journal Health Policy, Ellen Kuhlmann and colleagues discuss the need for a well-prepared and protected health and care workforce to ensure national security, health system resilience, and the provision of service in the context of a poly-crisis. They call for a coherent EU strategy to address persistent shortages, competency gaps and mismatches, and poor working and mental health conditions. They argue that addressing these challenges is essential for new health security and emergency governance frameworks to work effectively (EN).

As reported in an editorial from the Lancet Regional Health – Europe, more than 1,100 health care workers across Europe have warned that the broad detection measures negotiated under the EU Return Regulation could deter people from seeking health care and erode trust in the health care profession (EN).

In an article published in the Journal of European Social Policy, João Paulo Magalhães, Eleanor Brooks and Elke Heins examine the creation of the EU Social Convergence Framework (SCF). Introduced in 2024 as part of the reforms of the EU’s economic governance system, the SCF aims to identify risks and challenges to upward social convergence by focusing on labour market, education and skills, and social (including health) policies. The authors argue that, while the SCF increases the visibility of social indicators and may strengthen social objectives within EU governance, its reliance on soft law limits its transformative potential (EN).

In a viewpoint published in the Lancet Regional Health – Europe, Raffaella Ravinetto and colleagues draw the attention of European policy-makers to the need to improve access to medicines for neglected tropical diseases (NTDs). The prevalence of these diseases is low but increasing in Europe due to global mobility and climate change. The authors analyse the availability, affordability and accessibility challenges that some European countries face. They propose recommendations to ensure the sustainable availability and affordability of quality-assured medicines for NTDs across Europe (EN).

A new report from the World Health Organization’s Regional Office for Europe explores how EU Member States are approaching both the opportunities and the challenges of artificial intelligence (AI). It highlights emerging directions in strategic planning, regulatory alignment, capacity building and the responsible deployment of AI in health care (EN).