The CEO of the Bulgarian Association for Medicines Parallel Trade Development at Capital Health
Drug shortage is a pan-European problem that the European Medicines Agency (EMA) has related to the following main causes: shortage of raw materials in the manufacturing of medicinal products, problems with the requirements of good manufacturing practice, discontinuation of production of obsolete drugs or those with low profitability. The multifactoriality of the causes is also confirmed by periodically published reports of shortages of critical medicines in the United States, Serbia or Switzerland, where parallel distribution is not carried out. There is no such aggregate data for Bulgaria, but the Executive Agency for Medicines reports that in 2018, at the request of the marketing authorization holders, 221 marketing authorizations for medicinal products were terminated, none of them related to the safety of medicinal products. . For the period 2014 - 20197, deregistered medicines are more than 2,000.
Our initiative is to receive, service and assist patients who have difficulty finding their prescribed treatment. A year and a half ago, we proposed to the Federation "Bulgarian Patient Forum" (FBPF) to join efforts in the search for the real shortage causes, practically assisting patients in Bulgaria. Our alert platform was created as part of a joint action program with the FBPF, which was set out in a memorandum of cooperation. Our program also includes joint actions to build an effective regulatory framework to allow rapid delivery of proven drug shortages and regulate the import of medicines that have been deregistered for reasons other than pharmacovigilance. We tested the platform together with FBPF at their conference in June 2018. After successful testing, we published it on our website. BAMPTD also maintains a hotline to the platform through which it receives signals by telephone and through which fast feedback is sent to the transmitting signals via the Internet. For the period June 09, 2018 - November 25, 2019, 702 signals have been submitted and served from all over the country.
Here is a moment to express my gratitude for the trust to Ivan Dimitrov and the Federation Bulgarian Patient Forum with whom I have had the honor of working to assist Bulgarian patients over the last 13 years, first in the hospital field, and now for the access to medicines for which patients encounter difficulties. Together, we have conducted extensive patient training and the national FBPF structures have disseminated information throughout the country. We manage to provide feedback within 12 hours of reporting and resolve it within 32 hours with the help of partners across the drug supply chain.
Product deregistration and delivery rhythm disturbances account for 65% of the reasons for the lack of medicines that patients are seeking. That is why we interpret this 65% as deciding through more imports, rapid intra-Community supplies and allowing parallel imports as a tool to secure the market for medicines withdrawn from Bulgaria for economic reasons.
In over 35% of the cases we have found the required therapy in the settlement from which the signal was sent, and in the other cases we have provided valuable information for the patients. We are grateful that we are looking for the right answers and we are not robbing myths and this was appreciated.
In the second competition of the newspaper Capital and the biopharmaceutical company AbbVie "Innovations and good practices in the health sector" a total of 52 projects participated, and the competition presented the largest university public and private hospitals in Sofia, Plovdiv, Varna, Rousse and others. The finalists include teams of authors, physician teams, non-governmental organizations and specialist associations.
The competition introduced us to the outstanding achievements of medicine and pharmacy in Bulgaria. We thank the contestants for being here and having the power and ability to heal and help that way. The jury found it extremely difficult to determine the winners and this happened with very small differences between the projects. We believe that society needs to know even better what is happening in Bulgarian healthcare, major surgery, great science and medicine of the future. Therefore, we will summarize the submitted projects and they will be presented to the readers of Capital newspaper in a separate edition.
Patient organization project award
The award goes to a project that has been in the works for a year and a half. This is a missing drug search platform in an extremely convenient reporting format that requires no personal information, only the name of the medicine, location and telephone number. In addition to its founders, the heroes in this project are all marketing authorization holders, drug and drug wholesalers, who, along with the platform, helped over 702 patients find their medicine and guided patients on how to get their medicine.