Jan 30

President veto on legislative amendments to the Law on Medicinal Products for Human Use

  President Rosen Plevneliev imposes veto on the National Assembly’s legislative amendments to the Law on Medicinal Products for Human Use adopted on January 16, 2014, introducing a restrictive regime on exports of medicinal products , affecting the intra-Community supply of goods within the European Union.

  The President appreciates MPs’ will to ensure sufficient medicinal products to the population of the country, driven by the constitutional obligation of the state to ensure and guarantee the life and health of its citizens. Simultaneously, however, President Plevneliev notes that this obligation of the state is to be observed in accordance with the fundamental principles of the Constitution of the Republic of Bulgaria and European legislation, including those of equal business conditions and the constitutional state.

  New amendments create an obligation for wholesalers of medicinal products to submit a notification to the Bulgarian Drug Agency ( BDA ) for each export of medicinal products under the Positive Drug List out of the Republic of Bulgaria. Within 30 days from the date of notification , the Executive Director of the Agency shall provide an assessment of the request, only after the receipt of which the export in question is to be made.

  According to the head of state there should be a clear criteria in order to create equal business conditions for all exporters of a given product for a given period of time. The lack of clear criteria and placing business operators in a disadvantaged position creates conditions for subjectivity in the decision of the competent authority. The introduction of the notification procedure ( submission of notifications for export) has the characteristics of a license regime, which , in the absence of clear rules and criteria, creates a real opportunity for corruption practices. The President expresses his concern about the violation of Art. 19, para . 2 ab initio of the Constitution of the Republic of Bulgaria obliging the state to ensure uniform conditions for business to all citizens and legal entities.

  In addition to his his arguments for the veto Plevneliev also highlights the gap with art. 36 of the Treaty on the Functioning of the European Union prohibiting Member States to impose restrictions on imports , exports and transit of goods within the Community, resulting in random discrimination or a disguised restriction on trade between Member States.

  In violation of the Normative acts law and the Rules for the application of this act, the drafts of the medicinal products amendment act do not contain sufficient justification for the need for its implementation . Further lacks the necessary evaluation of the impact of the adopted amendments on medical institutions , patients and operators who conduct wholesale trade with medicinal products.

  The head of state expressed his hope that his motives would be accepted and the National Assembly would adjust the texts of the Law on Medicinal Products in Human Medicine with the Constitution of the Republic of Bulgaria, Art. 36 of the Treaty on the Functioning of the European Union and the provisions of the Normative acts law.