Dealers in medications on the Bulgarian market are obviously determined to resort to all possible tricks to save their business, which according to unofficial data amount to a total of 300 million levs per year. Originally the alarm came from the movement Bulgaria to Citizens. Its representatives asked the President Rosen Plevneliev to veto the texts of the Law on Medicinal Products for Human Use governing the parallel export of medicines. The main novelty in these provisions was to stop the export of drugs when it threatens to lead to depletion of these types of medications on the Bulgarian market, threatening the lives of patients. In essence, companies that make parallel exports (officially worth 85 million levs) must now notify the Bulgarian Drugs Agency (BDA) on the type and quantity of drugs they export. In turn, the health ministry is required in 30 days to verify whether drugs that are resold abroad are in enough quantities on the local market and thus give the green light to the transaction or prohibit it.
This seemingly innocent and absolutely legal control scheme obviously threatens the interests of big businesses. And resellers quickly found powerful allies. After the extra-parliamentary support Mr. Plevneliev himself took their cause to heart and vetoed the provisions in norm that introduce a „restrictive regime“ on exports. The President referred to the Article 36 of the Treaty on the Functioning of the European Union, although it regulates precisely the cases in which each member state can impose trade restrictions.
Meanwhile, the attack of Bulgarian Association for the Advancement of Parallel Trade in Medicines continued. An organization of publicly unnamed members invited members of the European Association of Pharmaceutical Companies and the German Association of Parallel Exporters to warn local politicians that due to such amendments in the law the country is threatened by a penal procedure by the European Commission. Intentionally or not, Germany is the country that is receiving the greatest part of parallel exports of other countries. The organization quoted results of a study which claims that 67% of Bulgarian hospitals have no shortage in medicines, and in the remaining ones the shortfall is due to registration problems or stopped imports of medications. Even so, this is only a half of the story. The other is – what happens to the pharmaceutical market that remained outside of the normative changes?
The parallel exporters were commented also by Gergana Passy, who was Minister for European Affairs in the tripartite coalition government. She noted that from a European perspective the current changes violated the free movement of goods within the EU internal market and opened the door for corruption. In practice, the European Commission has been approached with this matter, but a presidential veto delayed its answer as penal procedures are imposed only on already enacted legislation. That is to say the final decision is too early to get.
The legislative part of the case also has solid arguments. The draft amendments were submitted by MPs Nigyar Jaffer and Emil Raynov on the grounds that parallel exports are one of the reasons for the shortage of drugs for malignant cancer treatment, diabetes, epilepsy and Parkinson’s disease on the local market. Jaffer refers to the Constitution that authorizes the state to supervise and take restrictive actions in connection with the marketing of medicinal products. The Chairman of the healthcare committee in Parliament also argued that this is done when the shortage of a drug may threaten the health of citizens, and Directive 83 of 2001 the EU states that to protect the health and interests of the community stays in the first place.
The BANKER
