European Alliance for Personalised Medicine (EAPM) shared a post on LinkedIn:
“Europe’s Pharmacogenomics Moment: Modernize Now or Miss the Promise of Personalized Medicine.
Europe’s ambition to deliver the right treatment to the right patient at the right time will not be achieved with yesterday’s pharmacogenomics playbook. Pharmacogenomic (PGx) data already shape how medicines are developed, how trials are designed, what ends up in product information, and how clinicians dose and combine therapies. But sequencing, analytics and clinical deployment have advanced rapidly, while expectations for evidence, validation and implementation have not always kept pace.
That is why the European Medicines Agency’s concept paper on revising the Guideline on good pharmacogenomic practice matters. The EMA has opened a public consultation from 9 December 2025 until 31 March 2026. This is not a minor technical update: the revised guideline is intended to replace the current framework. If Europe wants precision medicine to be dependable, not boutique, stakeholders must engage now, while the foundations are being reset.
For EAPM, the priority is straightforward: make PGx trustworthy end-to-end. “Good practice” cannot stop at the laboratory bench. It must extend through validated bioinformatics pipelines, transparent variant calling and interpretation, clear genotype–phenotype logic, and disciplined lifecycle management as knowledge evolves. In 2026, opaque analytics are no longer acceptable.
The revision must also be clinically implementable. PGx only transforms outcomes when results are delivered in time, in a format clinicians can act on, and supported by decision systems that reduce uncertainty rather than amplify it. Europe cannot approve precision and then tolerate variability in reporting, actionability thresholds, or the translation from trial evidence to routine care. Regulatory guidance should reinforce, not fragment, the pathway from evidence generation to the prescribing decision.
Equity must be designed in, not bolted on. Pharmacogenes and variant frequencies differ across populations, Europe’s diversity makes this unavoidable. If evidence generation and interpretation do not account for that diversity, PGx will widen disparities instead of closing them. A modernised guideline should push for representativeness, explicit handling of population variability, and transparency about limitations.
EAPM urges developers, laboratories, clinicians, payers, HTA bodies and patient organizations to submit practical, implementation-focused comments-on methods, interpretation, reporting and real-world deployment. Europe can modernize pharmacogenomic practice now, lock in confidence, and accelerate uptake. Or it can spend the next decade explaining why personalized medicine failed to reach the patients who needed it most. This consultation is the strategic lever, leaving it unused would be a costly mistake.”
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