News, views and reports

This year has been intense for healthcare and life sciences in Europe and beyond. Looking back at the past twelve months, one thing is clear: Health policy is no longer a niche expert-only space; it is right at the center of economic, security, and climate debate and is increasingly intertwined with geopolitics, resilience, and Europe’s strategic autonomy.

Preparedness and health security

In the EU, health security and crisis preparedness have clearly moved up the agenda. The EU Preparedness Union Strategy, with its plans for common stockpiles of critical supplies and medical countermeasures, the renewed role of the Health Emergency Preparedness and Response Authority (HERA) under new leadership, and closer EU–Canada cooperation all signal a more structured and coordinated approach to future crises. At the same time, the slow and often tense negotiations on both the WHO Pandemic Agreementand the pathogen access and benefit-sharing system underline how difficult it remains to translate global solidarity ambitions into concrete rules governing access to vaccines, diagnostics, and treatments.

Medicine shortages and supply resilience

Alongside preparedness, structural vulnerabilities in Europe’s health systems are receiving renewed political attention. The proposed Critical Medicines Acthas opened up important debates on long-standing supply-chain dependencies, manufacturing capacity, and market incentives, reflecting a growing recognition that medicine shortages are not episodic failures but systemic risks that require coordinated EU-level solutions to ensure security of supply in the years ahead.

Vaccination back in focus

Vaccination policyhas also re-emerged as a central concern. What was long considered an established acquis in immunization can no longer be taken for granted. Falling vaccination rates in several Member States are contributing to the re-emergence of infectious diseases once thought to be under control, a trend compounded by persistently low influenza vaccination coverage among older populations . At the same time, progress in preventing vaccine-preventable cancers, such as those linked to HPV, remains uneven across regions. These challenges coexist with rapid innovation in vaccines, with mRNA continuing to be a major driver since COVID-19 and new frontiers opening in areas such as cancer vaccines and immunotherapeutic vaccines, including for HIV. Together, these trends highlight the growing gap between scientific progress and real-world uptake, policy coordination, and public trust.

Pharmaceutical Legislation and MedTech

Evolving regulation has also kept the pharmaceutical and MedTech sectors particularly busy. A key milestone came in December, when the European Parliament, Council and Commission reached a provisional political agreement on the revision of the EU’s General Pharmaceutical Legislation, marking the first major overhaul of the framework in two decades. The agreement introduced more streamlined regulatory timelines, adjustments to data and market protection, and a more calibrated approach to access-related obligations, representing a shift from the Commission’s original proposal. At the same time, elements such as a shorter baseline protection compared to today, the modulation of incentives, expanded shortage-related obligations, and a broader Bolar exemption continue to raise questions about long-term impacts on innovation, competitiveness, and supply resilience.

While technical drafting and formal adoption are still to come, the agreement underscored how central pharmaceutical policy has become to wider EU debates on access, security of supply, and industrial strategy. In parallel, MedTech companies continued to navigate the cumulative impact of MDR and IVDR implementation while preparing for compliance with the AI Act, with artificial intelligence in health increasingly framed both as an opportunity for earlier diagnosis and improved decision-making and as a regulatory challenge still seeking clarity in practice.

Biotech Act

A further development at year’s end was the European Commission’s first package of measures on health biotechnology, including the long-anticipated Biotech Act. The package aims to support biotech innovation and bio-manufacturing, accelerate and better coordinate clinical trials across Member States, and simplify regulatory procedures to reduce costs and speed up the development of new therapies. It also introduces a ‘Safe Hearts’ plan on cardiovascular disease and proposes steps to streamline medical device rules, with the overall objective of improving patient access while strengthening innovation and system sustainability. Stakeholders have highlighted the importance of clarity on how the Biotech Act will interact with existing clinical trials frameworks, as well as on the role of incentives such as intellectual property protection and reimbursement and approval timelines in supporting Europe’s biotechnology ecosystem.

Health and the environment

Another strong theme has been the intersection of health, climate, and the environment. There is growing recognition of the carbon footprint of European health systems and the need for green operations, supply chains, and procurement. The conversation widened further with renewed attention to pollutants, including PFAS findingsin blood samples of EU leaders. At the same time, progress on tobacco taxation and broader pollution control has been hampered by political divides, even as health evidence becomes increasingly hard to sideline.

Equity and access

Equity threaded through many of this year’s priorities. The first ever WHO resolution on rare diseasesmarked a major milestone, while concerns persisted about unequal access to orphan drugs and oncology products across Europe. Mental health also featured more prominently, especially the wellbeing of children and adolescents in an increasingly digital world. Yet implementation and investment continue to lag behind. The reduction of EU operating grants for health NGOs has further constrained civil-society organisations, at a time when independent analysis and patient perspectives contribute to the quality and balance of health policy development across the EU.

Trade and industrial policy

Trade and industrial policy have also been impossible to ignore, particularly as the United States placed pharmaceutical and medical technologies at the center of its tariff strategy. During the year, policy discussions and decisions unfolded against a backdrop of uncertainty, including adjustments to thresholds, temporary suspensions, and the eventual establishment of a 15 percent cap on tariffs for EU medicines exports. Within this context, companies across the sector have had to assess potential implications for long-term competitiveness, cost structures, and supply-chain resilience.

Industry organizations, including MedTech Europe, noted that reciprocal tariff scenarios could have disproportionate effects on smaller innovators and on the functioning of complex cross-border supply chains. The European Commission’s decision to establish a dedicated task force to coordinate with affected industries reflected the strategic sensitivity of these developments and the need for ongoing monitoring and dialogue. For export-oriented Member States and many SMEs, these trade dynamics translated into tangible operational considerations rather than abstract geopolitical developments, reinforcing how closely global trade policy is now linked to day-to-day business planning in healthcare and life sciences.

Women’s health and menopause

An area that personally stood out for me this year is women’s health, particularly menopause. Across discussions and policy forums, I am seeing and hearing far more calls for a dedicated European women’s health strategy, alongside demands for stronger investment in research and better data on conditions that disproportionately or uniquely affect women.

For a long time, menopause, in particular, received only limited attention at policy level, often confined to symbolic awareness moments rather than meaningful structural action. This year, however, brought a notable shift. During a Member State information session in August on the WHO’s programme of work on sexual and reproductive health and rights, the WHO explicitly included peri-menopause and menopause within its SRHR life-course frameworkand announced it is initiating new normative work on menopause and endometriosis. This is one of the clearest signals to date that menopause is moving from the margins into a formal global public health workstream. Taken together with the growing momentum in Europe, it raises an important question: Are we finally seeing the beginnings of a broader, long-overdue movement to address a severely important area of women’s health?

Personal takeaways

From a personal perspective, several reflections stand out. First, health policy is shifting away from a narrow focus on authorizations and budgets toward wider questions of sustainability, resilience and social responsibility. Second, the complexity of today’s policy environment has made transparent and balanced communication essential for navigating overlapping reforms, new AI rules, climate considerations and global trade pressures. Third, despite the unpredictability, there is a strong and committed community across patients, professionals, policymakers and industry leaders working to make health systems more equitable, innovative, greener and more sustainable.

Looking ahead

In 2026, we expect continued movement on the pharmaceutical package, preparedness strategies and the role of AI in health through the AI Act and other policies. We also expect women’s health, workforce shortages, and NCDs — including heart diseases, cancer and metabolic diseases — to remain high on the agenda, not only as health issues but as core pillars of Europe’s social and economic model.

As a team, we will continue to monitor these developments and contribute through policy insight, strategic advice, stakeholder engagement, and digital communication, with the aim of advancing better health. If we want innovation, competitiveness and preparedness to be credible, they must be shaped with patient access goals, climate responsibility and people centricity from the start, not as an afterthought.