In January 2014 the Bulgarian Parliament passed amendments to the Medicinal Products in Human Medicine Act (the Drug Law) aiming restriction of the parallel trade with pharmaceutical products exported from Bulgaria. The justification given for this action was to avoid shortages of medicinal products on Bulgarian market. Considering the lack of clear criteria regulating the export procedure in the proposed amendments the Bulgarian President imposed a veto. Parallel import/export of goods (including drugs) is a lawful form of trade within the internal market and strong justification is needed to apply the derogations regarding the protection of human health and life. The Bulgarian Parliament voted again consequently and a new chapter was added to the Drug Law: export of medicinal products. It was published and came into effect in March 2014.
The new provisions require those licensed wholesalers who intend to export from Bulgaria medicinal products included in the Bulgarian Positive Drug List to file a special notification form in advance. The notification form has to be submitted to the Bulgarian Drug Agency (BDA) on case by case basis and includes details of the planned export: name of the medicinal product(s), pharmaceutical form, quantity of active substance per dosage unit, identification number of the wholesale license, number of packs and importing country.
Based on the notification the BDA collect supply/consumption data for the past six months from the National Health Insurance Fund, Ministry of Health and the concerned marketing authorisation holder. The Executive Director of the BDA may ban the export of concerned medicinal products within 30 days after the date of notification in case of the following circumstance: (i) the quantities of the medicinal product subject to export (available as of the date of the notification to the BDA) are not sufficient to meet the needs of the domestic market; (ii) there is risk of temporary shortages of the medicinal products as a result of the export; (iii) the shortage may cause serious danger for human health and life. There are penalties provided for not submitting an export notification: the fines are between EUR 25,000 and EUR 100,000.
However, the actual criteria for analysing the collected data and considering the potential risks remained relevantly vague. In an effort to make the procedure more clear and transparent in April 2014 the BDA published Rules for assessment of the export notifications available on their website. The document aims to clear out the risk indicators and to build a system for analysis, monitoring and risk management in view of shortages of medicinal products for the Bulgarian market.
The restriction of the parallel trade could be questionable and we have yet so see the response of the Commission in the Bulgarian case. Estonia, Spain, Greece and Portugal have already faced similar issues as far as the restriction of exports could be contrary to the free movement of goods principle within the European Union.
Update. A ruling dated January 29, 2015 of the Bulgarian Constitutional Court repealed the grounds for the Bulgarian drug Agency to block parallel export of medicines from Bulgaria. According to the Constitutional Court the export procedure set in the Drug Law is in contradiction with the principles of equal treatment of market players and of proportionality. The main issue found by the court was the lack of clear criteria when considering “insufficiency” and “temporary shortage” of medicinal products for the Bulgarian market. The outcome of the ruling is that the Bulgarian Drug Agency is not allowed to ban planned exports any more but the notification procedure was not revoked – remaining as a monitoring tool only.