Bulgaria’s rebate policy risks limiting medicine access

Sofia’s deepening reliance on mandatory rebates shifts the healthcare deficit onto companies and jeopardises patients’ access to treatment, the pharmaceutical industry has warned.

The Association of Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharm) argues that the policy threatens the availability of innovative therapies, puts pressure on the long-term sustainability of the healthcare system, and could leave Bulgarian patients further behind their EU peers.

Bulgaria must increase medicine budgets and reduce the financial burden it places on pharmaceutical companies, said Deyan Denev, Executive Director of ARPharM-Bulgaria, in an exclusive interview with Euractiv.

Mandatory returns

The National Health Insurance Fund (NHIF) will spend €1.55 billion on medicines in 2026, but the state requires the pharmaceutical sector to return at least €450 million.  According to the industry, this indicates the hidden healthcare budget deficit that is transferred onto pharmaceutical companies in the form of mandatory price rebates.

ARPharm Bulgaria estimates that in 2026, the hidden deficit transferred to pharmaceutical companies will exceed 30% of NHIF payments to hospitals and pharmacies. This means the state will spend more on medicines while demanding a larger-than-planned reimbursement from the industry.

“The distribution of this payback burden is uneven. The most affected are the most effective therapies, which doctors prescribe to an increasing number of their patients; i.e., the volumes reimbursed by NHIF grow compared to the previous year. In some cases, pharmaceutical companies must return to NHIF amounts exceeding the revenues from the sales of the respective medicines,” Denev said.

Impact on patients

He warned that if the government does not reduce the hidden deficit by paying for the medicines it orders, the consequences will be severe.

“Thousands of Bulgarian patients will be deprived of the opportunity to benefit from the latest advances in patient care, access to new therapies will be delayed for years, and the burden on the hospital system and chronic diseases will increase,” the ARPharM-Bulgaria director noted.

According Denev, depriving patients of innovative therapies because the government refuses to pay for them could lead to higher costs for hospitalisations, longer stays, deteriorating quality of life for patients and lower workforce productivity.

“Bulgaria risks falling behind other EU countries in terms of access to innovation and modern therapies,” Denev said.

The Trump effect

Earlier this year, ARPharM-Bulgaria warned that the issue of mandatory rebates also affects many US companies operating in Europe and Bulgaria, which could attract the attention of Donald Trump against the backdrop of escalating tariffs.

At the end of September, the Health Ministry proposed changes to rebate rules, which appear to serve only the state’s interests and deepen the dispute with the pharmaceutical industry in Bulgaria.

The health insurance fund plans to collect even more pre-agreed rebates from pharmaceutical companies in 2026. The new system is expected to bring the state an additional €63 million per year.

Therapies out of reimbursement

The problem of the hidden deficit and mandatory rebates does not seem to be helping Bulgaria’s healthcare system. Next year, eight innovative therapies will not be reimbursed by the state, while companies refused to sign rebate agreements for four innovative medicines under the current conditions.

There are also cases where pharmaceutical companies have not applied for the inclusion of their medicines in the state-funded positive medicines list at all.

The introduction of additional rebates and increases in existing ones may discourage companies from bringing new therapies to the Bulgarian market. This year, the state raised the required rebate for medicines without an analogue from 10% to 15%.

For next year, a minimum rebate of 5% is introduced for medicines with a new international non-proprietary name submitted for inclusion in the positive medicines list.

“The new rebate rules will lead to more efficient use of public funds, a reduced risk of budget deficits and long-term stability of the health insurance system regarding medicine payments,” the Health Ministry commented.

“Bulgaria risks falling behind other European countries in terms of access to innovation and modern therapies,” Denev said.

[VA, BM]

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