Bulgaria’s new government has pledged a comprehensive review of the national medicines policy to tackle what it called an “overregulated” pharmaceutical market.
Deputy Health Minister Petar Salchev has highlighted concerns about significant price disparities in the procurement of high-cost medicines that lack market authorisation in Bulgaria by state-owned hospitals. According to Salchev, excessive regulation of the Bulgarian pharmaceuticals market has contributed to systemic weaknesses and inefficiencies.
Low prices limit access
Bulgaria’s medicines market is relatively small, while government requirements that medicines be purchased at the lowest available prices within the EU have discouraged pharmaceutical companies from registering innovative therapies for legal sale in the country.
Nearly a decade ago, the Bulgarian parliament introduced a temporary solution by allowing hospitals to purchase medicines without marketing authorisation through direct negotiations with suppliers. However, the measure led to substantial differences in the prices individual hospitals paid for the same medicines, prompting allegations of misuse of public funds allocated for pharmaceuticals.
“Our team places a particularly strong emphasis on cost-effectiveness, not only regarding healthcare services reimbursed by the National Health Insurance Fund, but also in relation to pricing. The large disparities in the prices of medicines purchased by healthcare institutions are unacceptable,” Health Minister Katya Ivkova said.
Healthcare reform, more needed
The new Bulgarian government, led by Prime Minister Rumen Radev, has promised a multi-layered reform of the healthcare system. Among its key commitments are improving access to and the quality of healthcare services, as well as expanding patient access to innovative therapies.
Speaking to Euractiv, ARPharM Bulgaria Executive Director Deyan Denev argued that access to innovative medicines can only be improved if Bulgaria abandons its policy of seeking the lowest possible prices and reduces the mandatory commercial rebates required of pharmaceutical companies.
A recent industry survey found that 75% of pharmaceutical companies expect delays in launching new medicines in Bulgaria over the next one to three years. Two-thirds of respondents also said they may decide not to introduce some innovative therapies to the Bulgarian market at all.
Industry stakeholders argue that the newly installed government should prioritise three key reforms to reverse the trend. The first is a sustainable increase in public spending on medicines, with companies maintaining that pharmaceutical innovation can no longer be financed primarily through increasingly burdensome payback mechanisms imposed on manufacturers. However, this is likely to prove a difficult challenge for Radev’s government, whose immediate priority has become tackling rising food prices and avoiding an excessive budget deficit.
Economic experts have warned that, without fiscal reforms and a freeze on certain public expenditures, Bulgaria’s budget deficit could rise to as much as 7% of GDP.
At the same time, the health ministry must address the growing debts of state-owned hospitals, which stood at €426 million, equivalent to around 0.4% of GDP, as of 31 March this year, further increasing the risks associated with an excessive deficit.
[VA, BM]