Bulgaria’s new government has voiced its first public position on the EU’s legislative procedures surrounding pharmaceuticals. Sofia insists that the EU’s Critical Medicines Act (CMA) should have clauses allowing voluntary implementation.

As discussions evolve around the pharmaceutical package and the new CMA initiative, Sofia has said it remains firm on its right to independently determine its drug policies.

“Bulgaria expects the Critical Medicines Act to provide an opportunity for initiatives and measures on a voluntary basis among willing member states,” the Bulgarian Ministry of Health told Euractiv. 

Retain national autonomy

The insistence on maintaining control over pharmaceutical policy was reinforced last year by a series of Bulgarian court decisions which reduced the government’s control over hospital spending. The court’s decision is expected to cause a sharp increase in public healthcare spending, by at least 15%, reaching €5 billion – equivalent to 4.7% of GDP.

Sofia claims to “appreciate the need for readiness and the EU’s efforts to ensure sustainable supply chains and access to critical medicines,” but is keen to maintain control.

“In this context, as well as taking into account the competencies in the healthcare sector at EU level, we believe that the proposed measures should be adapted so as not to limit the autonomy of member states guaranteed by EU primary legislation, including not to create mandatory requirements for harmonised procurement, stocks or the like at EU level,” the health ministry told Euractiv.

Proportionate financial involvement

Bulgaria has also deemed it equally important to ensure a smaller financial commitment under the Critical Medicines Act, taking into account the local economy’s smaller size.

“The financial commitments of the Member States (under the CMA) must be proportionate to preserve the financial sustainability of national health systems, which are currently facing a number of challenges,” the Government has said.

Additionally, any new medicines initiative at the EU level should be developed based on a prior analysis, solid available scientific data and an impact assessment.

“Only by following such an approach will it be possible for Member States to effectively coordinate the implementation of the set objectives so as to ensure maximum improvement in access to medicines in each individual EU country. In this sense, we expect the proposals in the Act to be based on the necessary impact assessment and data-based analysis,” the government explained.

Bulgaria’s stake

The CMA is being developed as an EU regulation with the aim of, among others, facilitating investment in the production of critically important medicines in the EU and making supply chains faster and more sustainable.

It should enable member states to unite in common markets for the production and trade of medicines in order to increase their purchasing power. The Act also provides guidelines on state aid to help member states financially support such strategic projects.

Bulgaria has a significant interest in the new European legislation, as it may help overcome the difficulties in negotiating lower prices that arise from its relatively small market, given it has a population of 6.4 million people.

The pharmaceutical industry has blamed the government for excessive bureaucracy, which also hinders access to innovative drug therapies. Patients have access to half as many innovative therapies as in Germany.

Over the past year, the government has begun to impose permanent bans on the export of medicines due to market shortages, which have affected antibiotics for children and several diabetes medications.

[Edited by Vasiliki Angouridi, Brian Maguire]