Bulgaria has announced urgent measures to reduce bureaucratic obstacles to the importation and distribution of essential cancer treatments in an effort to address growing shortages.

“The new measures affect over 40 cancer drugs, and the government’s goal is to prevent the risk of Bulgarian citizens being deprived of health insurance coverage for the basic therapy for their disease,” the Bulgarian government has said.

Privately supported budget

Pharmaceutical companies operating in the Bulgarian market have repeatedly complained about the cumbersome procedures for exporting and re-exporting drugs that affect Bulgarian patients. These procedures often lead to shortages and higher prices on the free market.

At the same time, the government heavily relies on large discounts from pharma companies for reimbursed medicines.

As Euractiv reported, pharmaceutical companies in Bulgaria demand an increase in the state budget for medicines, as the system is currently supported by discounts private businesses give.

Bulgaria’s cancer burden

According to the OECD/European Commission Country Cancer profile, Bulgaria is one of only two EU countries to have experienced increased cancer mortality over the past decade.

Higher mortality is recorded even though estimated cancer incidence rates in 2022 were lower than the EU averages for both men and women in Bulgaria, and cancer mortality rates in 2021 were close to the EU averages.

According to the data, avoidable mortality from three of the most common types of cancer – lung, breast and colorectal – is higher in Bulgaria than the EU average. The gap in avoidable mortality between the country and the EU increased between 2011 and 2021 – especially for colorectal and lung cancers among men.

Bulgarian patients face financial and organisational difficulties accessing treatment, even though public funding has more than doubled in the past five years.

Now, for the first time, the Bulgarian government admits that the administrative burden on pharmaceutical companies and drug importers is causing problems in treatment access.

New measures

The government is proposing new rules for regulating and pricing essential oncology products. The aim is to quadruple the period for mandatory review of changes in the prices of essential oncology drugs – from six to 24 months.

This measure will significantly ease the administrative burden on pharmaceutical companies and allow for the long-term preservation of products in the Bulgarian market.

The government has previously acknowledged that the local pharmaceutical market is unattractive for drugs in global shortage because of its smaller size.

These measures aim at reducing bureaucracy and facilitating the trade of scarce therapies.

The second key change is the establishment of a separate state budget for essential oncology drugs to guarantee health insurance coverage for basic cancer treatments.

This approach aims at ensuring continuous access to necessary medicines for patients with oncological and oncohematological diseases and the sustainability of the budget.

The government has stated that “The Ministry of Health remains committed to ensuring timely and effective treatment for all patients and will continue to work for the stability of the drug policy in the country.”

Lawsuit lingers

Sofia is facing an EU Court of Justice lawsuit over preferential treatment given to private oncological hospitals in the country.

For a decade, the National Health Insurance Fund (NHIF) paid different prices to public and private hospitals for the same cancer medicines. In some cases, private hospitals pay up to 10 times more than public hospitals. In both cases, the money is reimbursed by the NHIF.

Bulgarian legislation obliged state hospitals to uphold public procurement processes for medicines, while private hospitals bought them after direct negotiation with traders, who, in some cases, were affiliated with them.

The different legal treatment led the European Commission to start infringement procedures against Bulgaria for non-compliance of the national law with the European rules.

[Edited by Vasiliki Angouridi, Brian Maguire]

Source: Euractiv.com