76th WHO Regional Committee for Europe: Roadmap for action on artificial intelligence in health in the WHO European Region 2026–2033

On 29 October 2026, IFPMA delivered a statement on the roadmap for action on artificial intelligence in health in the WHO European Region 2026-2033 at the 76th WHO Regional Committee for Europe in Copenhagen.

We welcome efforts by WHO EURO to establish a pragmatic set of priorities toward meaningfully advancing AI in health. These efforts should build on existing legal and regulatory frameworks, including intellectual property frameworks and TRIPS, while promoting greater regulatory coherence and harmonization. We emphasize the importance of proportionate, evidence- and risk-based approaches that avoid duplication, regulatory fragmentation, and the introduction of unnecessary national requirements. In the EU context, implementation should build on the EU AI Act and relevant sector-specific legislation.

IFPMA welcomes the Roadmap's emphasis on trust, accountability, and ethical governance as foundations for the responsible integration of AI into health systems. We support a human-centered, risk-based approach that embeds ethical considerations throughout the AI lifecycle, with appropriate safeguards and oversight proportionate to the context and potential risks of use. Guided by the IFPMA AI Ethics Principles, the research-based pharmaceutical industry promotes high standards of integrity in its own use of AI. We also welcome the Roadmap's emphasis on collaboration and partnerships, including across the AI value chain, to foster responsible innovation, clarify roles and responsibilities, and advance consistent approaches to ethical governance while building on existing frameworks.

We further welcome the focus in strategic area three on high-quality, representative data and robust digital infrastructure, which are essential foundations for reliable and trustworthy AI in health. Many countries are establishing or evolving their health data governance frameworks and strengthening data linkage across levels of care. These efforts can support stronger, more resilient health systems and improved healthcare delivery.

We also welcome the roadmap's recognition of the importance of enabling the use of health data to support research, including by private entities. As countries advance their digital infrastructure and governance, we encourage greater alignment and interoperability across national frameworks, avoiding fragmentation and establishing clear, predictable pathways for responsible access to, sharing, and analysis of health data for research and innovation. Regulatory oversight should respect the mandates and expertise of existing competent authorities, ensuring that AI applications are governed by the appropriate bodies according to their intended purpose and context of use, including where relevant medicines and medical device regulators.

The innovative pharmaceutical industry relies on well-designed data governance frameworks and predictable cross-border data flows to develop medicines and vaccines, generate evidence, and advance biomedical innovation, as described in the IFPMA publication on International Data Flows. Data governance frameworks should protect individuals while enabling responsible data use for research and innovation across borders. We encourage continued multistakeholder collaboration, including with the pharmaceutical industry, to build trusted and interoperable health data ecosystems that support research, innovation, and better health outcomes for patients and populations.