In Romania, generic and biosimilation treatments – essential drugs for millions of patients – are accessible on paper, but blocked in practice. Although 70% of patients are treated with such alternatives, bureaucracy, outdated legislation and unrealistic prices make these drugs be late on the list of compensated, supports the Association of Generic Medicines in Romania.
Drugs. Photo Archive Truth
According to the Association of Producers of Generic Medicines in Romania, 70% of patients are treated with generic and biosimilation. And 90% of these drugs cost below 50 lei.
We remember that generic drugs They are copies of the original drugs (also called “innovative”) whose patent has expired. They have the same active substance, the same dose and the same therapeutic effect, but it costs significantly less – because they no longer include the initial research and development costs.
And bIosimilate They are the equivalent of generics for biological drugs – that is, those treatments produced from living cells, commonly used in cancer, autoimmune or rare diseases. Although more complex and more expensive than classical generics, biosimilations are, in turn, more accessible alternatives to original biological drugs.
22 months for a generic oncological drug
“A generic cancer medicine needed exactly 22 months from the moment the price was approved until it was actually available compensated. During this time, patients had only limited access to it, because the innovative drug was on a cost-volume contract“, Explained Daniel Bran, president of the Association of Generic Medicines Manufacturers in Romania (APMGR).
The problem comes from the fact that, in Romania, after the expiration of the patent of an innovative drug, the generics are not automatically entered in the list of compensated. The producers must resume a complex bureaucratic route, which often lasts up to two years. During this time, patients remain without treatment, and drugs sometimes become destroyed by lack of use.
Increases and withdrawals from the market
In addition to bureaucratic blockages, patients also face the increase of drugs. From April 1, 2025, some drugs have increased by up to 6.25%, especially the non-compensated ones. Cause? A global crisis of raw materials, excipients and packaging, which started in pandemic and has now accentuated, due to instability in the key markets-India and Pakistan, where many companies had a monopoly on active substances.
At the same time, “The prices of the compensated drugs have not changed, but for this reason the suppliers do not bring them to the market-it is simply no longer profitable. Prices are set on old formulas that do not reflect current costs. This leads to the withdrawal of the products and the impossibility of patients to continue their treatment ”warns Vasile Barbu, president of the National Association for Patient Protection.
High costs, low yield
The development of a biosimilar drug costs between 150 and 300 million euros, and Romania, although it has a relevant pharmaceutical industry – contributing 1.1% to GDP – fails to create stable conditions for manufacturers. The low, not actualized prices and the lack of an automatic inclusion system in the list of compensation discourages investments and drives out the producers.
In Germany, patients can receive a generic drug even from the day following the approval, and the offer is 6-8 times richer than in Romania. In Norway, things go as quickly: generics and biosimilations are immediately compensated and used almost exclusively
What does the industry propose to unlock generic access?
According to a statement, the Association of Producers of Generic Medicines in Romania (APMGR) proposes a series of concrete measures for recovery:
- Review of the reference price mechanism and the annual indexation of prices below 50 RON depending on the inflation, to maintain the economic viability of these treatments.
- Reduction of the clawback quota – an additional fee paid by manufacturers – from 15% to 10% for generics and 5% for biosimilation, essential treatments but with small profit margins.
- The modification of the legislation so that the generic drugs equivalent to the innovative (in cost-volume contracts) are included in the compensation list in maximum 2 months.
- The adoption of a firm position from Romania to European level, by requesting the European Commission to include the Directive on residual urban waters in the Omnibus simplification legislative package – an initiative that can reduce the administrative tasks that also affect the pharmaceutical industry.
The association of generic drug producers in Romania (APMGR) was established in 2009 by a group of high quality generic drugs. It is a non-governmental, independent organization, which aims to extend access to treatment and support a balanced pharmaceutical policy in Romania.
