Better medicines, medical devices and technologies: Government approves single national assessment mechanism

The Republic of Moldova is introducing a single national mechanism for assessing medicines, medical devices and other medical technologies financed with public funds. Funding decisions will be based on clear and transparent criteria—including scientific evidence, patient benefit, health needs and the efficient use of public resources. Today, October 21, at the proposal of the Ministry of Health, the Government approved the decision on the national health technology assessment (HTA) mechanism.

“This is an important project because every leu spent on healthcare must contribute to improving people’s health. We spend approximately 20 billion lei through the National Health Insurance Company, within the mandatory health insurance system, of which 3 billion lei goes toward medicines. Therefore, we must make the best decisions about how we spend this money so that we achieve the greatest possible impact on people’s health,” said Prime Minister Vasile Tofan.

Until now, decisions regarding the reimbursement of medicines, centralized procurement or the financing of treatments through national programs were made through different procedures, without a single mechanism to correlate clinical benefits, costs, budgetary impact and patients’ needs.

The new mechanism will enable the comparative assessment of medical technologies, taking into account their effectiveness and safety, the severity of the disease, the availability of therapeutic alternatives, cost-effectiveness and the impact on the public budget. Unmet medical needs will also be considered, including those of patients with cancer, rare diseases and other serious conditions.

“When we decide to finance a medicine or medical technology with public funds, the question should not be only how much it costs, but what real benefit it brings to the patient, how safe and effective it is, and how many people we can help with the resources available. Not every new technology is automatically better, and an effective treatment should not be inaccessible simply because it is costly. We need evidence-based decisions, responsible negotiations and fair rules for patients. This is the purpose of the mechanism we are introducing,” said Minister of Health Alexandru Gasnaș.

The process will have clearly defined stages. The Medicines and Medical Devices Agency will receive the dossiers and conduct the technical assessment. The results will also be examined from the perspective of value for patients and society, and, when necessary, negotiations will follow regarding the price and financing conditions. The decision will be formalized through an order issued by the Minister of Health, followed by monitoring of the technology’s use and the results achieved.

An important change is the use of scientific assessments already carried out at European level or in other countries. The Republic of Moldova will be able to use these results after verifying their relevance to the national system, focusing assessment resources on local costs, available alternatives, the number of eligible patients and the capacity of medical services.

Price cuts, agreements based on the number of patients treated and contracts under which suppliers assume some of the financial risks or risks related to treatment outcomes may also be negotiated. These instruments can facilitate access to costly innovative treatments while protecting public funds.

For patients, the new mechanism aims to ensure more predictable and equitable decisions regarding access to treatments, while for the healthcare system it will support the use of resources where they can produce the greatest benefits.

Implementation will be phased. Starting January 1, 2027, the mechanism will apply to medicines proposed for public funding; from January 1, 2028, to all relevant medical technologies; and from January 1, 2029, it will become the sole method for including and maintaining medical technologies in public funding. Technologies that are already funded will be reassessed gradually and will continue to receive funding until reassessment, while essential medical technologies will benefit from a distinct regime to ensure continuity of patient access.