OBJECTIVES : Parallel exports of medicines from low-price European Union (EU) countries to high-price EU countries can lead to low stocks in the former. This study shows for the first time the extent of parallel trade of cancer drugs exported from Romania and the impact on cancer patients.

METHODS : Parallel exports officially notified to the Romanian National Agency for Medicines and Medical Devices between March 2017 and December 2017 were obtained and analyzed. Pharmaceuticals reimbursed under the publicly-funded National Oncology Program which were exported through parallel trade were identified. Quantities were expressed as a percentage of the annual average volumes reimbursed by the Romanian National Health Insurance House in the previous year (2016). Calculations were made separately for each pharmaceutical form/dosage. Generic alternatives were considered.

RESULTS : 39 INNs of the 113 cancer medicines analyzed were at least once parallel traded from Romania during March 2017 – December 2017, summing 136.925 therapeutic units in various pharmaceutical forms. The study identified one cancer drug for which 49% of the average annual reimbursed quantity was exported through parallel trade from Romania, four cancer drugs for which more than 15% of the average annual reimbursed quantity was parallel traded and three cancer drugs for which quantities between 7%-12% were parallel traded. Of the 23 cancer drugs reported as missing on the Ministry of Health online platform, 11 were parallel traded during the period analyzed: for two of them the parallel traded quantity exceeded 18% of the average annual reimbursed quantity.

CONCLUSIONS : During 2017, parallel trade of cancer drugs from Romania was significant in terms of quantity. Expressed as a percentage of the average annual reimbursed quantity, parallel traded quantities for five cancer drugs exceeded 15%. National and EU level policies are needed to avoid the negative effects of parallel trade on patients’ access to treatment.