Bulgaria’s government approved on December 13 a bill of amendments to the Medicinal Products Act that aims to limit exports of medicines in cases when such drugs were in short supply or outright not available.
The issue has gained prominence in recent weeks after law enforcement agencies announced a major bust of an organised crime group, whose members are alleged to have acquired medicines with costs partially covered by the National Health Insurance Fund, using fake prescriptions, and then sold the drugs abroad.
The amendments envision that the state medicines executive agency will have to build a new electronic registry that will collect the data on the availability of all medicinal products in Bulgaria. It would be required to do so within four months of the law going into effect.
Furthermore, the agency will have to draw a list of drugs that could potentially be subject to export limitations, under clear and objective criteria, under new regulations that will have to be drafted by the Health Ministry. The agency will also be tasked with issuing export bans, but only in cases where it can show a shortfall in drugs necessary to cover the needs of Bulgarian patients.
Additionally, the bill mandates the Health Ministry to issue a new regulation covering the use of medicinal products for compassionate use. These are treatment options that allow the use of unauthorised medicine for patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.
In the EU, the use of medicinal products for compassionate use is covered by a directive dating back to 2004, with the European Medicines Agency providing recommendations to individual member states, which in turn set their own regulations.
“This way, patients will receive access to treatment when having no other alternatives and medicinal products are not certified in other countries,” the cabinet’s media office said in a statement. Such treatments, however, would not receive state subsidies through the National Health Insurance Fund.
The bill also features amendments on clinical trials that implement EU regulations, detailing organisational rules and clarifying which medical facilities can carry out clinical trials, the statement said.
(Photo: Brian Hoskins/sxc.hu)