In recent years, Romania has introduced key updates to its pharmaceutical regulations, impacting drug pricing, reimbursement policies, and procurement procedures. These changes are designed to improve medicine accessibility while maintaining the financial sustainability of the healthcare system. However, for hospitals and pharmaceutical companies, adapting to these regulations requires careful planning to avoid supply disruptions, cost inefficiencies, and compliance risks.
Understanding these regulatory shifts will allow healthcare decision-makers to anticipate challenges and develop strategies that support both operational efficiency and patient care.
New Drug Pricing Regulations: Stricter Cost Controls
Romania follows a reference pricing system to set the maximum manufacturer price for medicines. The proposed price must not exceed the lowest price of the same drug in 12 reference countries, including Bulgaria, Hungary, Germany, and Italy.
Certain high-cost medicines (such as immunologics and plasma-derived treatments) are subject to even stricter controls, with pricing capped at the average of the three lowest prices among these countries.
Implications for Hospitals and Pharmaceutical Companies
- Limited drug availability: Manufacturers may be discouraged from supplying medicines in Romania if pricing regulations make the market unprofitable.
- Potential supply disruptions: Hospitals should prepare for shortages, especially for specialized treatments.
- Cost planning challenges: As reference prices fluctuate across Europe, hospitals must monitor procurement budgets closely.
That said, hospitals and pharmaceutical companies should proactively track price adjustments and engage with multiple suppliers to mitigate the risk of availability issues.
Reimbursement Delays: A Growing Backlog
The National Agency for Medicines and Medical Devices (NAMMD) determines which drugs qualify for reimbursement through Health Technology Assessments (HTAs). Medicines can receive either unconditional or conditional reimbursement approvals.
However, conditional approvals often require additional agreements, such as cost-volume or cost-volume-result contracts, to manage financial risks.
One major challenge is the delay in reimbursement approvals, especially for conditionally approved medicines. These delays create a backlog of unreimbursed indications, meaning hospitals and pharmacies may struggle to stock newer treatments.
What This Means for Hospitals and Pharmacies
- Delayed patient access to new medicines: Treatments approved elsewhere in Europe may take longer to become available in Romania.
- Uncertainty in hospital budgets: Delays in reimbursement approvals complicate cost planning for healthcare institutions.
- Increased administrative burden: Hospitals must dedicate more resources to tracking reimbursement status and securing interim solutions.
Pharmaceutical companies should actively engage in HTA evaluations to ensure faster inclusion in reimbursement lists. Hospitals can plan alternative treatment options for patients affected by reimbursement delays.
Procurement Regulations: New Distribution Requirements in Romania
To stabilize the supply of medicines, the Romanian government has introduced new procurement rules designed to reduce dependency on a single supplier and improve market availability. These changes affect both manufacturers and hospital procurement teams, requiring adjustments in distribution and purchasing strategies.
Key Requirements for Manufacturers
The National Agency for Medicines and Medical Devices (NAMMD) is responsible for ensuring compliance with these new regulations. Marketing authorization holders (MAHs) must adhere to the following:
- Distribute through at least three wholesalers – Manufacturers are now required to work with a minimum of three authorized wholesalers, reducing reliance on a single distributor.
- Obtain necessary authorizations – Companies must secure appropriate licenses for wholesale distribution, following Romania’s national pharmaceutical regulatory framework.
- Maintain a continuous supply – Manufacturers must ensure consistent product availability by collaborating with multiple wholesalers to prevent shortages.
Impact on Hospital Supply Chains
To further support supply stability, the Ministry of Health has expanded centralized national tenders. While this aims to improve cost efficiency in hospital procurement, it also introduces new challenges:
- More complex supplier management – Hospitals must coordinate purchases with multiple distributors, increasing administrative workload.
- Potential delays in deliveries – The centralized tendering process can be time-consuming, leading to temporary supply gaps.
- Price fluctuations – While centralized procurement may lower costs, variations in supplier availability could impact short-term pricing and accessibility.
How Hospitals and Pharma Companies Can Adapt
To comply with the three-wholesaler distribution rule and minimize supply chain disruptions, hospitals and pharmaceutical companies must adopt more flexible procurement strategies.
1. Diversify suppliers
Working with multiple wholesalers ensures compliance with the new regulations while reducing dependency on a single distributor. This approach helps mitigate supply chain risks, improves medication availability, and provides hospitals with greater flexibility in sourcing essential drugs.
2. Prepare for fluctuations in drug availability
Maintaining a reserve of alternative treatment options ensures that patient care is not disrupted when certain medications become temporarily unavailable. Hospitals should regularly review supply trends, update formularies with suitable substitutes, and leverage reliable sources of real-time medication data to make informed decisions.
3. Optimize participation in centralized tenders
While national tenders can reduce procurement costs, hospitals must carefully evaluate suppliers’ ability to deliver medications consistently and on time. Assessing past performance, contract fulfillment rates, and potential delays will help prevent unexpected shortages and ensure a stable supply of essential medicines.
The Bottom Line
Romania’s new pharmaceutical regulations introduce both opportunities and challenges for hospital administrators and pharmaceutical companies. While stricter price controls and reimbursement delays require careful financial planning, procurement adjustments can help stabilize medicine supply.
A key challenge in this new procurement environment is maintaining real-time visibility into medication availability and alternatives. Solutions such as Apollo AI Technologies can support hospitals by providing accurate, continuously updated information on all authorized medications in Romania.
Using advanced artificial intelligence algorithms, Apollo AI processes data from over 8,500 official documents, offering precise answers to questions about drug availability, alternative treatment options, and regulatory compliance. By integrating such technology into procurement workflows, hospitals can make more informed purchasing decisions and ensure uninterrupted patient care.
