New medicines law provides for manufacturers to report shortages promptly

Manufacturers and marketing authorization holders will be required to give timely notice of possible interruptions to the production or supply of medicines. This is one of the measures set out in a new law being prepared by the Ministry of Health, with the aim of giving healthcare institutions time to secure alternative treatments when shortages arise.

The draft law sets out stricter rules on the availability, safety and quality of medicines, as well as mechanisms for addressing shortages of specific treatments in a timely manner. The proposals also include making the counterfeiting of medicines a criminal offense.

Speaking at a national consultation organized in cooperation with the World Health Organization, Health Minister Sasho Klekovski said the current law dates from 2007 and has been amended more than 20 times. For that reason, he said, an entirely new legal framework is needed.

The proposed law will cover medicines only. Medical devices and pharmaceutical activities are expected to be regulated later through separate laws.

Reporting shortages and securing treatments

The mandatory shortage notification procedure is intended to give institutions time to respond to production or supply problems. Klekovski said many such situations can be anticipated and called for better coordination between institutions and suppliers. He cited the medicine “Dekotin” as an example, saying it is currently in persistent short supply.

Addressing shortages of treatments at clinics, including the Oncology Clinic, the minister said alternative solutions would be sought for patients. He also stressed that public procurement contracts should provide for penalties when supplies are not delivered by the specified deadline.

The ministry also plans to discuss with the Health Insurance Fund the introduction of long-term financial planning for medicine procurement.

Measures against counterfeit medicines

The draft law includes new rules on reporting adverse effects of medicines and aligning domestic legislation with European standards. Klekovski said stricter measures against counterfeit medicines will also require alignment with the Criminal Code, so that counterfeiting is addressed separately in criminal legislation.

Positive list and next steps

The new law is expected to simplify some medicine registration procedures and improve monitoring of medicine consumption. The data collected will be used to assess the financial feasibility of expanding the positive list. Klekovski said he expects new medicines to be added to the list in 2027.

The World Health Organization’s representative in the country, Dr. Akim Ali, welcomed the preparation of the new law. He said modern legislation is essential to ensure citizens have access to safe, effective and affordable medicines.

Representatives of patients, doctors, pharmacists and the pharmaceutical industry are taking part in drafting the law. Their comments and suggestions will be reviewed before the draft law is submitted for government consideration.