Romanian drugmakers seek strategic status as import dependence raises shortage risk

Industry calls for national strategic status

Romanian pharmaceutical manufacturers should be treated as strategic entities and supported by a clear national industrial policy, according to Dragoș Damian, executive director of the Romanian Industrial Medicines Manufacturers Association, PRIMER, and CEO of Terapia Cluj. His warning centers on Romania’s dependence on imported medicines and the risk that insufficient domestic capacity could leave the country exposed when regional supplies tighten.

As reported by Știri de Cluj, Damian said Romania has neither attracted enough foreign capital into pharmaceutical manufacturing nor sufficiently encouraged domestic investment in new medicine plants. He argued that the absence of a national strategy has increased reliance on neighboring countries and other external suppliers. His proposal would place local drugmakers within a sector formally regarded as being of national interest.

Taxes add pressure to local production

Damian contrasted Romanian policy with measures adopted elsewhere in Europe. He cited Hungary’s elimination of value-added tax on reimbursed medicines as an example of government action that can lower medicine prices and reduce costs for the health system. In Romania, VAT on medicines increased from 9% to 11%.

Romanian producers also pay a clawback tax ranging from 15% to 25%, according to Damian. He said the combined burden creates obstacles to medicine access by adding costs to a market in which many established products already sell at low prices. For manufacturers, the central issue is whether regulated prices and reimbursement conditions allow continued production when operating and logistics expenses rise.

The debate also covers the role of generic medicines. Commenting on statements by interim Prime Minister Ilie Bolojan about using generics instead of more expensive innovative products, Damian said the distinction does not concern quality, efficacy or safety. Once a patent expires, other manufacturers can produce medicines with the same active ingredient, generally at a lower price. That can allow the health system to treat more patients while easing pressure on its budget.

Shortages sharpen the case for reshoring

Supply interruptions are especially serious for inexpensive generic medicines. Damian identified several possible causes, including technical problems at manufacturing sites, increased demand in particular markets, and higher production and transport costs. These factors can make continued supply commercially difficult even when demand from patients remains strong.

At European level, greater local production of critical medicines is being discussed as a way to reduce import dependence. The reshoring approach aims to locate manufacturing of essential products closer to the markets where they are consumed, strengthening supply chains and reducing the risk that medicines disappear temporarily from pharmacies and hospitals.

Damian said Romania produces only 2% of the European Union’s medicine requirements. The figure underlines both the limited scale of the country’s manufacturing base and the challenge facing policymakers: measures intended to improve affordability must also preserve incentives to manufacture low-priced products. Strategic status alone would not expand capacity, but it could provide a framework for tax, investment and industrial measures designed to keep essential production economically viable.