Moldova has set out a national health technology assessment framework that would bring medicines and other health technologies into a common route for evidence assessment, economic evaluation, negotiation and public-funding decisions. The detailed model moved into stakeholder scrutiny at a public meeting on 29 July.
The Medicines and Medical Devices Agency (Agenția Medicamentului și Dispozitivelor Medicale, AMDM) would become the national technical HTA authority. The Ministry of Health (Ministerul Sănătății, MoH) would retain the final administrative funding decision, with separate councils responsible for deliberation, economic negotiation and appeals.
Economic assessment would include cost-effectiveness, budget impact and sensitivity analysis. The draft sets a reference threshold of no more than 0.7 times GDP per capita for each quality-adjusted life year gained, with progressively higher levels requiring stronger justification. Values above three times GDP per capita would be reserved for defined circumstances including rare diseases, orphan medicines, advanced therapies and advanced or terminal disease with added therapeutic value.
Exceeding the relevant threshold would not automatically preclude funding. It could instead trigger economic negotiation or a risk-sharing agreement. Negotiation could also follow high budget impact, uncertainty over eligible patient numbers or a need for volume limits, budget caps, rebates or refunds. Confidentiality provisions would protect the effective net price.
Simplified assessments without deliberation or negotiation would take up to 120 calendar days, compared with 270 days for full assessments.
Implementation would start with priority medicines during 2026, expand during January-May 2027 and cover medicines proposed for public funding from June 2027. Systematic application to other relevant health technologies, including medical devices, is planned from January 2028. The model would give Moldova an explicit route for connecting value assessment with negotiated and managed access to publicly funded innovation.
Source: Medicines and Medical Devices Agency
Link: Consultări publice privind proiectul Hotărârii Guvernului cu privire la mecanismul național de evaluare a tehnologiilor medicale (Public consultations on the draft Government Decision concerning the national health technology assessment mechanism)
Date: 30 July 2026
Source: Ministry of Health
Link: Notă de fundamentare la proiectul de hotărâre de Guvern cu privire la mecanismul național de evaluare a tehnologiilor medicale (Explanatory note to the draft Government Decision concerning the national health technology assessment mechanism)
Date: 30 June 2026
