Bulgaria pitches fast domestic authorisation of innovative drugs to attract pharma firms

Bulgaria will rely on the speed and efficiency of its domestic authorisation procedures for innovative drug therapies to attract the interest of pharma companies to its small domestic market, the Ministry of Health told Euractiv.

Bulgaria has been in a severe political crisis for over three years, witnessing three government changes in the last eight months alone. Prime Minister Nikolai Denkov's regularly elected government resigned in March 2024. Since then, president Rumen Radev has appointed two caretaker governments of GERB-affiliated Prime Minister Dimitar Glavchev.

However, Bulgaria's official position in the negotiations on the EU's pharma package has not changed significantly.

Faster regulatory procedures

Denkov's pro-European government sent the framework of pharma package positions, and Bulgaria seems to be sticking to it so far.

The caretaker government, which will remain in power until at least mid-November, is focused on ensuring the freedom of smaller and poorer countries like Bulgaria to offer faster procedures to pharma businesses.

This seems to be one of the only ways to attract the interest of big pharmaceutical companies, motivating them to offer their innovative therapies in these not very solvent markets.

The Bulgarian government insists on finding a balance at the EU level to promote the necessary innovations that are rewarded accordingly without hindering the market entry of generic and biosimilar medicines as a means of improving competition in the EU and reducing the cost of medicines for health systems.

"We believe that the pharmaceutical package should be fully in line with the EU's delegated competence, which excludes the harmonisation of decisions in areas related to the organisation and financing of health care, including national level decisions on pricing and reimbursement," the ministry said.

They emphasise that for Bulgaria, it is particularly important that decisions remain within the powers of the EU member states for activities that are subject to national competence. This relates to health technology assessment processes, pricing and reimbursement, and drug budgeting.

Larger and smaller markets

When implementing the EU pharmaceutical package, a distinction must be made between smaller markets, such as Bulgaria, and larger markets for the legislation to be effective, commented Bulgarian MEP Tsvetelina Penkova (S&D) in an interview with Euractiv Bulgaria.

She also spoke about the key need for Bulgaria to guarantee equal access to innovative drug therapies. This is a substantial problem for Bulgarian patients, with recent market studies showing they have access to 50% fewer innovative therapies than Germans.

"When negotiating the pharmaceutical package of the EU, Bulgaria must focus on equal access to all types of medicines. At the EU level, it is necessary to ensure that there will be no member country whose citizens do not have access to lifesaving and life-sustaining medicines. This is still happening and is unacceptable," Penkova commented.

She emphasised that, for poorer countries, using concessions to negotiate access to innovative therapies is strategic, as it will help to provide treatments more quickly, especially for rare diseases.

"There is a need to facilitate access to innovative, new and advanced therapies, especially for rare diseases. "Also, work must be done to negotiate favourable conditions that will allow timely treatment, resources for research, and guarantee the possibility of obtaining the necessary medications for every citizen and patient in need," Penkova explained.

According to Penkova, Bulgaria and the EU should focus on creating regulatory flexibility in the pharmaceutical market, which also means reducing the current bureaucratic burdens.

Penkova also pointed to a problem which is not receiving much attention - that prescriptions issued in Bulgaria are not accepted in some EU countries, creating conditions for a double standard towards Bulgarian citizens. "This must come to an end," she says.

[Edited by Vasiliki Angouridi, Brian Maguire]