Bulgaria Probes Regulatory Barriers in Supply of High-Cost Medicines

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The Commission for Protection of Competition has launched an in-depth inquiry into whether Bulgaria’s regulatory framework for supplying high-cost medicines is restricting competition and driving inefficiencies in public spending.

The investigation focuses on medicines that are not authorized for use in Bulgaria but are nonetheless reimbursed with public funds—a niche but critical segment of the pharmaceutical market with direct implications for patient access and healthcare budgets.

Concerns Over Price Disparities and Procurement Practices

The probe was initiated following a report by Vasil Pandov, which highlighted big price differences for identical medicines across hospitals. Publicly available data suggested that procurement practices may be contributing to these discrepancies.

According to the report, hospitals have been sourcing such medicines without conducting open procedures under Bulgaria’s Public Procurement Act. This raises concerns about transparency and the efficient use of public resources, particularly given the high cost of these treatments.

Structural Issues Identified

In its preliminary findings, the CPC identified several structural weaknesses in the current system. Notably, the absence of centralized framework agreements negotiated by the Ministry of Health appears to limit purchasing power and coordination.

At the same time, hospitals—acting as contracting authorities—have been awarding contracts for small quantities over short timeframes. This fragmented procurement approach can lead to higher unit prices and less favorable contractual terms, ultimately increasing costs for the public sector.

Advocacy Proceedings Signal Broader Regulatory Review

Rather than pursuing a traditional enforcement case, the CPC has opened competition advocacy proceedings. This tool allows the authority to assess whether existing legislation and administrative practices are compatible with competition principles.

As part of the process, the CPC will conduct a comprehensive market analysis and gather input from stakeholders, including public institutions, suppliers, and healthcare providers.

The proceedings are expected to culminate in a set of recommendations aimed at eliminating or mitigating anti-competitive effects while preserving the legitimate objectives of healthcare regulation. These may include proposals to amend or repeal specific legal provisions that distort market dynamics.

Expanding Use of Competition Advocacy

The case also signals a shift in the CPC’s enforcement strategy. Competition advocacy proceedings have historically been underutilized by the authority, but are now set to play a more prominent role as a tool for reviewing regulatory frameworks across sectors.

By focusing on systemic issues rather than individual company conduct, the CPC is positioning itself to address competition concerns at their source—potentially reshaping how regulated markets function in Bulgaria.