AIPM has submitted a draft proposal to harmonize the registration of orphan medicines in the EAEU

At the panel session of the «Pharmprojections» Conference in Minsk, the AIPM presented its position on establishing a unified process for granting the orphan status to medicines in the region, which would improve access to modern therapies for patients with rare conditions.

According to the AIPM, one in every five new medicines planned for registration over the next 5 years is an orphan medicine. In oncology this figure is one-third, while in neurology it is 40 percent.

Their model is based on 3 scientifically supported criteria:

1. rarity of disease (less than 10 in 100,000 people);
2. severity of illness (based on current criteria for conditional approval);
3. unmet medical needs or significant improvement over existing treatments.

The initiative involves 3 steps: agreement on common standards, establishment of unified procedures (one application - one review - one decision), ensuring recognition after registration in all countries. It's important to note they propose leaving pricing and reimbursements (compensations) at national levels, like in the EU.

AIPM emphasizes that introducing this unified model would allow all special regulations of EAEU countries to be applied to speed up market entry of medicines in all 5 countries, which is crucial for patients with serious, rare, and debilitating conditions.

AIPM proposal will be discussed within working groups of the Eurasia Economic Commission.