OBJECTIVES: Poland is currently experiencing drug shortages due to illegal export. Polish authorities have taken several measures to prevent this. The aim of this study was to review the recent attempts to solve this problem and their impact on the number of products at risk of shortages.

METHODS: A literature review was conducted in Embase, Medline, websites of major public Polish institutions, pharma blogs, news and Google using free terms to identify the most important attempts to solve the problem of illegal drug export.

RESULTS: Poland has implemented several legislative changes to reduce the problem of drug shortage due to illegal export since 2015, when its value reached 2 billion PLN annually. The most important changes, resulting from amendments to Pharmaceutical Law, included requirement for the consent of Chief Pharmaceutical Inspectorate for export of drugs vulnerable to shortages; obligation of manufacturers, wholesalers and pharmacies to report state of warehouses, sales volume, intention of export; justification for refusal of drugs delivery and imposition of financial penalties. Past measures however seem insufficient. Despite gradual decrease between July 2015 and January 2016 from 257 to 142, the number of the products vulnerable to shortages started to increase in 2016. It stabilized in the middle of 2016 at the level of approximately 200 products and continues like this up to now. Further changes are planned e.g. introduction of Integrated System for the Monitoring of Trade in Medicinal Products (execution planned for June 2018), imprisonment for violation of law, inclusion of drugs into Monitoring System for the Road Carriage of Goods (planned for June 2018).

CONCLUSIONS: Illegal drug export remains a challenge in Poland. Previous legislative efforts to eliminate the problem did not prove so far to be effective. Further research is warranted to inform if the most recent changes translate into drug shortage reduction.