Hyötyriskiarviointia

Hyötyriskiarviointia, literally meaning “benefit–risk assessment” in Finnish, is a systematic process used to evaluate the advantages and disadvantages of a product, intervention or policy. The method is commonly applied in the pharmaceutical, medical‑device and financial sectors to support decision‑making by regulators, market‑authorizers and other stakeholders.

In pharmacology, the Finnish Medicines Agency (Fimea) requires a benefit–risk assessment for each new drug application. The assessment examines clinical efficacy data, safety profile, and population‑specific factors such as age or comorbidities. Evidence is gathered from clinical trials, post‑marketing studies, case reports and pharmacovigilance databases. The results are then weighed against alternatives, therapeutic options and the unmet medical need, producing a recommendation for approval, conditional approval or rejection.

The assessment framework follows principles similar to those adopted by the European Medicines Agency, including quantitative benefit–risk methods such as weighted scoring, risk–benefit plots and value‑based decision analysis. In addition to regulators, hospitals and insurance funds use benefit–risk data to negotiate pricing, reimbursement and prescribing guidelines.

Beyond drugs, benefit–risk analysis is increasingly applied to medical devices and health‑care technologies, ensuring that innovations meet safety standards while delivering real patient benefit. The Finnish approach emphasizes transparency, evidence‑based evaluation and stakeholder participation, making hyvityriskiarviointia a cornerstone of evidence‑based health‑care policy.