Fast track for EU registered medicinal products and easy access to unauthorized medicines in Bulgaria proposes BAMPTD
Non-export bans, green lines and solidarity between EU countries guarantee access to medicines
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 corona virus 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by the patients themselves, as the medicines are either not registered in Bulgaria or have been, but have been withdrawn from the Bulgarian market. 27 are the signals for lupus and rheumatoid arthritis.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.