1512 medicines have been withdrawn from the Bulgarian market for the last 4 years, said Boryana Marinkova, Executive Director of the Bulgarian Association for Medicines Parallel Trade Development. This was made clear at a workshop in Pamporovo of the Bulgarian Patient Forum Federation and BAMPTD.
Over 6 months on the online drug availability platform, 400 alerts were received.
In 62% of cases, the causes of drug shortages concern temporary or permanent discontinuation of medicines and deregistered medicines, which dossiers have been deleted from Bulgaria at the request of their primary importers. “And which doctors continue to write and patients continue to search without being available on our territory,” Boryana Marinkova, BAMPTD CEO, said for Bulgarian National Radio.
Parallel exports as a problem of drug shortage in Europe is not a leading cause, but on the contrary – it can help to tackle the shortage, Marinkova says. Pointing to the introduction of the drug stock monitoring system, she hoped by a legal mechanism to introduce proactive measures, not just a ban on exporting drugs to situations of shortage.
“There will not just be a drug that will be banned for export, and there will be a procedure for very rapid parallel imports of this medicine.”
Boryana Marinkova expressed the view that it is good with amendments to the LMHM to allow parallel imports of deregistered medicines not withdrawn from Bulgaria due to drug safety problems.In the year 2017, 327 medicines were deregistered without any of them having a drug safety problem, she said.
In about three weeks, through parallel imports, with all regulatory requirements, missing medicines can reach the Bulgarian consumer, BAMPTD states. “That is, at the first signal that there is a problem, it may take up to two or three weeks to respond, which is a reasonable time and patients not to feel acute shortages,” said Boryana Marinkova.
At European level, we have access to a 500-million-Euro market in partnership with more than 100 distributors, she added.
The online platform, established jointly with the Bulgarian Patient Forum Federation, which has been in operation since June 9, has received 400 signals for six months. According to Marinkova, this is a very intense period of signaling against the backdrop of patient feedback so far.
The signals received are for 274 medicinal products. Over 85 percent of alerts are received by the end user – patients or their relatives. There are also reports from the media and from the National Health Insurance Fund.
The whole interview can be listened HERE