The risk of shortage of medicines – COVID-19


The declared state of emergency by a decision of the National Parliament allowed the Minister of Health to issue an order of 20.03.2020, by virtue of which the export of quinine-based medicines is prohibited. The purpose of the ban is to meet the needs of the Bulgarian market in connection with the complicated epidemiological situation in the country due to the spread of COVID-19.

Meanwhile, the National Parliament voted on explicit provisions entitling the Minister of Health to ban the export of medicinal products, whereas envisioning fines amounting up to BGN 100,000 (EUR 51,000). We are to follow the exact texts of the adopted provisions, which will be promulgated in the State Gazette.
At the same time, the European Commission is working to adopt measures aimed at safeguarding the free movement of all goods and, in particular, guaranteeing the supply of medicines, medical equipment and food.
The Association of the Research Based Pharmaceutical Manufacturers in Bulgaria and its member pharmaceutical companies (ARPharM) announced that the immediate risk of shortage of medicinal products due to COVID-19 is minimal in the short term and the organization does not expect disruption of the drug supply chains, unless the restrictions due to COVID-19 outbreaks last more than a few months.
The team of Penkov, Markov & Partners, which specializes in the Pharmaceutical Matters has extensive experience in advising pharmaceutical companies affiliated with ARPharM and the European Federation of Pharmaceutical Industries and Associations (EFPIA) and is available for any consultation and assistance.

The above provides general information related to the adoption of the Emergency Measures and Actions during the State of Emergency Act and it is not exhaustive, whereas it serves only as a guide for interpreting the news as of March 22, 2020. 

For more information and answers to specific questions related to your business, you can contact us at:  lawyers@penkov-markov.eu.