Bulgaria extends ban on exports of insulin, antibiotics for children [Advocacy Lab Content]

2 months ago 13

Bulgaria continues to experience serious medicine supply problems, leading caretaker Health Minister Galya Kondeva to extend the export ban on antibiotics for children, insulin and blood sugar-lowering drugs until mid-July.

Earlier this year, the health ministry launched a major inspection of drug warehouses across the country. After the inspection showed “irregular deliveries, delays or refusal by the drug warehouses to deliver medicines to the pharmacy network”, an export ban on medicines was imposed.

However, the continued imposition of temporary measures raises suspicions of a permanent ban on re-exporting certain medicines, contrary to the Treaty on the Functioning of the EU.

“The export of medicinal products for the treatment of diabetes and of antibacterial medicinal products for systemic use, as well as the observed delays in supply, disturbs the balance between the medicinal products supplied in the country and the increased demand for them to meet the health needs of the population,” the health minister said.

Recurring bans

The ban on the export of medicines will last at least until 17 July 2024 but will most likely be extended again. Currently, Bulgaria imports most medicines from Romania and exports most to Poland.

Bulgaria first imposed restrictions on insulin exports in October 2023; in April 2024, it banned exports of antibiotics for children. Since then, bans have been renewed periodically due to supply problems, mainly because of insufficient availability of Fiasp, Tresiba and Xultophy insulins. There have also been problems with some of the common antibiotics for children.

The country’s political crisis has prevented parliament from taking permanent measures to address the drug shortages. The outgoing Bulgarian government proposed a bill that would automatically block the export of medicines if 100% of the required quantities to satisfy the domestic market were not provided.

However, the bill was not passed due to the collapse of the ruling majority, and the current rules of banning exports at 65% of domestic supply remained.

EU Treaty violation

The European Commission (EC) had expressed reservations about the Bulgarian state’s proposed legal changes and insisted that Bulgarian companies be free to import and export medicines.

The Commission announced that Bulgaria was about to violate the EU Treaty by blocking “the free movement of medicinal products within the internal market.”

There is a high chance that the draft law will not be adopted at all because the main parties in the new parliament, GERB and DPS, are hesitating about whether these measures are necessary, Euractiv has learned.

In case of a critical shortage, Bulgaria can request assistance from the European Medicines Agency (EMA) in order to use European mechanisms for its management and mitigation.

In 2023, the European Commission started preparing a list of critical medicines in short supply in the European Union. Based on this list, a mechanism for voluntary solidarity sharing and exchange of medicines between Member States will be established in 2024.

Rigid parallel import procedures

In February, the Bulgarian Association for Medicines Parallel Trade Development, which brings together companies involved in the re-export of medicines, accused the government of causing the shortage of medicines.

According to the Association, rigid and slow administrative procedures have been imposed for the entry of parallel-imported medicines into the Bulgarian market. In some cases, drugs in short supply in the Bulgarian market wait for over 100 days to get a retail price to sell in pharmacies.

Parallel trade of medicines is allowed and encouraged in the European Union, whereby a medicine intended for one market is bought and traded in another within the union.

More than 320 parallel-imported medicines are imported into Bulgaria, and some antibiotics and diabetes medicines wait in warehouses for between two and six months to get a retail price.

[By Krassen Nikolov, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]