Drug manufacturers warn: delays in compensation affect patients

Generic drug manufacturers in our country point out that the introduction of treatments on the compensation list occurs with delays of up to two years. In parallel, while production costs are increasing, the prices of generic drugs have been constantly decreasing in the last decade, which risks leading to the withdrawal of essential therapies from the market.

• Increasing costs, decreasing prices

"In the last 10 years, while the costs of raw materials and industrial goods have increased by 30-45%, the prices of generic drugs have been constantly decreasing," said Călin Băjan, leader of the working group for prices of the Association of Generic Drug Manufacturers of Romania (APMGR). He emphasized that the current system requires the application of the lowest price and the payment of the clawback tax, without the possibility of adjustment according to economic realities. In these conditions, inflationary pressures, new environmental requirements and the costs associated with caring for an aging population are jeopardizing the availability of treatments.

• Major delays in treatment reimbursement

Simona Cocoş, member of the APMGR Board of Directors, explained that generic and biosimilar medicines arrive on the List of unconditionally reimbursed medicines with delays of 1.5-2 years. "We have a significant share of innovative medicines both in terms of volume and amount, and treatments that can be solved with generic medicines, due to delays in the system, are solved at prices two to three times higher than innovative ones,” Cocoş pointed out at an event organized by the Coalition of Organizations of Patients with Chronic Diseases and APMGR.

• Low share, major impact

Although they generate substantial savings for the budget, generic medicines represent only 20% of total spending on medicines in the health system, according to data presented by APMGR. Between 2016 and 2023, the introduction of generics brought a budgetary optimization of over one billion euros, and the contribution to the state budget was 1.56 billion lei, equivalent to 0.3% of the budget.

• An export-oriented market

Currently, approximately 40% of the production of generic medicines in Romania goes for export. This situation reflects the industry's difficulties in remaining competitive on the domestic market, where regulations and administrative delays affect profitability and patient access.

Manufacturers warn that, if solutions are not found to make the compensation system more flexible and to adjust prices to economic realities, Romania risks losing access to essential treatments and incurring much higher costs by using innovative medicines exclusively.