More Effective Drugs, Medical Devices, and Technologies: Moldovan Government Approves Unified National Assessment Mechanism

Starting in 2027, decisions on which drugs, medical devices, and treatments will be funded from the state budget will become transparent and will be based not only on price but also on the actual benefit to the patient.

Previously, decisions on drug reimbursement or centralized procurement were made through various, often opaque procedures. The new system aims to change this.

As Prime Minister Vasile Tofan noted, out of the 20 billion lei spent through the compulsory health insurance system, 3 billion goes to drugs, and every lei must bring maximum benefit to people's health.

What will be considered when assessing drugs?

The new mechanism introduces clear criteria that are particularly important for patients with severe, oncological, and rare diseases. When assessing a drug or technology, the following will be taken into account:

• Clinical efficacy and safety (based on scientific evidence).
• The presence or absence of alternative treatments.
• Unmet medical needs (a key factor for patients with rare diseases).
• Cost-effectiveness ratio and impact on the state budget.

'The question should not only be about how much it costs, but also about what real benefit it brings to the patient... Not every new technology is automatically the best, and effective treatment should not become inaccessible just because it is expensive,' emphasized Health Minister Alexandru Gasnas.

Smart Contracts: How the Government Plans to Procure Expensive Drugs

One of the most important innovations for patients will be the ability to conclude innovative agreements with suppliers. Instead of simply purchasing a drug at a high price, the state will be able to negotiate volume-based discounts (the more patients treated, the lower the unit price) and outcome-based payments, known as risk-sharing. In this case, if the treatment does not yield the expected effect, the supplier refunds part of the funds or assumes the financial risks.

This is a global practice that already allows many countries to provide patients with expensive gene therapies and innovative oncology drugs without breaking the budget.

How will the process work and when will it take effect?

The implementation will be phased to avoid chaos. From January 1, 2027: the mechanism will apply to new drugs seeking state funding. From January 1, 2028: to all relevant medical technologies and devices. From January 1, 2029: this will become the only legal way to include technologies in the state funding system.

An important guarantee for patients: Technologies already being funded will not be abruptly canceled. They will undergo a gradual reassessment. And for vital medical technologies, a special regime will be introduced to ensure uninterrupted patient access to treatment during the assessment period. To speed up the process, Moldova will rely on existing scientific assessments conducted at the European level, adapting them to local realities.