16 February 2015
Recently introduced amendments in Bulgarian Medicinal Products in Human Medicine Act (“MPHMA”) required the wholesalers to notify in advance Bulgarian Drug Agency (“BDA”) and to obtain permission for export of medicinal products listed as per the Positive Medicinal List, including when the export is for another EU member state. The applicable criterion, in general, was that the export shall be permitted if it shall not result into or pose a risk of insufficiencies of the respective medicinal product on the internal market.
By virtue of Ruling No. 1 dated 29 January 2015 of the Constitutional Court of the Republic promulgated in the State gazette on 13 February 2015, these amendments were declared unconstitutional. The Constitutional Court found that this regulation is arbitrary and the criteria laid down are non-specific, as well as it limits the free economic initiative guaranteed by Article 19 of the Constitution disproportionally.
The effect of the Ruling is that as of 17 February 2015 this amendment of the MPHMA shall not apply. However the other regulations under “Export of Medicinal Products” Chapter of the MPHMA shall remain effective.
Therefore, the obligation to notify the BDA in the event of export of medicinal products listed under the Positive Medicinal List as per Article 217b and Article 217a, para.4 of the MPMHA shall remain effective while the permitting of the export by the Executive Director of the BDA shall no longer be necessary.
Now the government should find another solution in compliance with the Constitution and the European rules on free movement of goods against the parallel export of reimbursed medicinal products which often result in shortage of drugs for certain diseases.