Press releases

The Association offers fast track for importing EU medicinal products and facilitated access to unauthorized medicines in Bulgaria 

82 alerts were submitted from March 13 to April 27, 2020 by patients on the online platform for medicines' lack and shortages. With them, the total number has increased to 922 since the system started functioning, announced the Bulgarian Association for Medicines f Parallel Trade Development (BAMPTD) in connection with the interim reporting of the results of patients' signals. 

The leading reason are the unauthorized in Bulgaria and the deregistered products, because of which 81% of the signals are submitted to BAMPTD hotline. A significant proportion (32%) of these are publicly commented preparations undergoing clinical trials for the treatment of coronavirus disease. The others, however, are therapies for chronic diseases. These medicines have so far been purchased from foreign countries by the patients themselves, as the medicines are either not registered in Bulgaria or have been, but have been withdrawn from the Bulgarian market. 27 are the signals for lupus and rheumatoid arthritis. Fewer signals are about deregistered epilepsy products, hormone replacement drugs, etc. 

12% of patients submit about breast cancer drug with temporary imports suspension from February this year. They have been fully serviced as since February 18, 2020 continuous parallel import of the same product from Europe was initiated by the member of BAMPTD - BestaMed. This is further evidence that green lines, no export bans and solidarity between countries across the European Union, linked to the entire drug supply chain, guarantee access to medicines and are effective prevention of their scarcity and shortage, BAMPTD emphasizes. 

The response of end-users in a state of emergency differs from the results so far in that it shows difficulties in adhering to therapy with deregistered and unauthorized products. This result confirms the proposal of BAMPTD for amendments to the Law on Medicinal Products in Human Medicine and Ordinance 10 of 17.11.2011 on the conditions and procedure for treatment with medicinal products not authorized for use in the Republic of Bulgaria, as well as the conditions and procedure for inclusion , changes, exclusion and delivery of medicinal products from the list under Art. 266a, para. 2 of the LMPHM. 

Ordinance 10 applies only to patients admitted to hospital. The decision according to BAMPTD is to adopt texts in the L:PHM that allows import of medicinal products registered in the European Union and the extension of the regime of Ordinance 10 with import of unauthorized but prescribed by doctors medicines for outpatient treatment. Opportunities for treatment with unauthorized and withdrawn products will facilitate access to therapy for many patients with prescribed home treatment after discharge from a healthcare facility and under the supervision of their physicians. 

BAMPTD is calling for changes to import EU-registered medicines, promote rapid intracommunity supplies, accelerated deadlines and more efficient parallel import procedures. Specific texts have been submitted to the Ministry of Health and the National Assembly and their adoption will be of benefit to the health system and the society. 

The Platform is online at www.parallel-trade-development.org and is supported by BAMPTD in partnership with the Federation of Bulgarian Patients' Forum. The hotline operates 24 hours a day so far for more than 20 months with the primary purpose of facilitating patients' access to therapy. It is an internet-based alert form that requires only a residential area, phone number and a sought after drug, and complies with GDPR.

The European associations representing manufacturers of medicinal products, parallel distributors, healthcare distributors and pharmacists welcome pan-European efforts by the Heads of Medicine Agencies1, the European Medicines Agency, the Council2 and the European Commission3 to address medicine shortages. Supply chain stakeholders believe that the longterm resolution of medicines shortages is dependent upon collaborative and unified actions. We therefore call for the inclusion of the supply chain actors in the abovementioned initiatives organized by Governments and the regulatory community.

Ahead of the Bulgarian Presidency event ‘Health as the Real Winner: Presidency conference on options to provide better medicines for all’ on 6 March in Sofia, supply chain stakeholders call for their greater involvement in discussions about medicines shortages. Specifically, supply chain stakeholders wish to make the Health Ministers aware of an existing collaboration on this crucial issue, created with the objective of helping to mitigate the impact of shortages. Furthermore, supply chain stakeholders strongly believe that the input, perspectives and experience of the variety of stakeholders affected by the issue of shortages needs to be sought and taken on board to reach best-informed conclusions.

The supply chain partners have set up an informal working group in 2015 and published a set of recommendations in early 20174 calling for greater transparency and availability of medicines shortage data, early detection and assessment of potential shortages, consistency of reporting, increased access to the information available across all parts of the supply chain, improved data infrastructure, and collaborative stakeholder governance processes.

The Associations’ statement4 is part of their wider commitment to tackling the increasing problem of shortages across the European Union, having a significant impact on patients, health professionals, healthcare systems and manufacturers and distributors.