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Permission for parallel imports from the past has ensured the availability of oncology medicine in our country

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Permission for parallel imports from the past has ensured the availability of oncology medicine in our country

Encouraging the import of medicines will ensure patient access, BAMPTD stated during the 2019 Capital Innovation Almanac of Healthcare Innovation Conference

The first platform for drug shortage signaling in Bulgaria was presented by Boryana Marinkova, Executive Director of the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD) at the Capital of Health Forum 2019 Almanac of Innovations in the Healthcare Forum held today. It is recalled that BAMPTD received the first prize in the Second Health and Innovation Contest for its online platform. “It was created in conjunction with the Bulgarian Patient Forum Federation and has been operating for over a year. We tested the platform at their conference and trained the patient organization’s representatives on how to deal with it,” Marinkova explained. It is easy to use as it only enters the name of the missing medicine from which the signal is located and the feedback telephone to the feeder. “Our main goal was to identify patients’ real problems with drug shortages. In Bulgaria there was no information on the causes of the shortage. On the first day we received over 100 signals within 2 hours” said Boryana Marinkova.

From 2014 to 2019, 1748 medicines were withdrawn from the Bulgarian market, and in 2019 there were 236 against 15 new licenses issued. “The landscape is inhospitable, to say the least. Our data are based on 818 received signals, of which 70% are from patients, 10% are from relatives of patients, there are parents as a separate category, because child care is a priority for us, there are signals from doctors, pharmacies, from health fund, patient organizations and media,”explained Boryana Marinkova. In 93% of the cases the products are medicines, about 3% are for food supplements, 1% are medical devices. In 99% of the cases, feedback was established to resolve the signal and close the case, the rest were invalid, errors, etc. In 32% of cases, drugs were available – ie. found not in the first pharmacy, but in many others in the same town. However, 19% of the signals are medicines with permanently suspended imports – they will no longer be available in Bulgaria. At 16% the reason is temporary suspension of imports. For 15% of the signals it turns out that the drugs are not registered in our country.

BAMPTD spoke specifically about some patient alerts. The first signal for the absence of a medicine for breast cancer with the active ingredient tamoxifen 10 mg was received on February 12 this year. “There were still residues then, but the next day it was gone. It turned out that one of the members of BAMPTD had been authorized to parallel import this medicine in the past. The batch was released and the signals were satisfied. The permit is valid and thanks to it can be reacted to at the moment. If it had to be new, it would take maybe 90 days. We urge that fast parallel imports be regulated rather than relying on chance, as in this complex and important case,” said Boryana Marinkova.

In the second case an immunosuppression drug has not been available in Bulgaria since 2018, but is found for parallel import from a neighboring country. It has already been submitted, but it still faces administrative barriers to price registration. The case remains unresolved as of March 14, 2019, despite the parallel import authorized by the BDA.

“Our conclusions are that the shortage of medicines in our country is due to the fact that Bulgaria is not attractive for new products, it is very unattractive and to remain registered products for economic reasons. On the other hand, there are delays and inefficiencies when specific problems with the availability of medicines need to be resolved”, Marinkova summarized. This year BAMPTD chairs the Bulgarian Organization for the Verification of Medicines (BgMVO). “There is no better time for Bulgaria to open up to rapid intracommunity deliveries and to promote parallel distribution and import than the one in which we have a system of protecting patients from counterfeit medicines, which operates across Europe. Concurrent distribution affects the EU, where all state-owned companies operate under similar regulatory rules and mechanisms. At this point we can consider the European market to be completely safe and secure and our appeals to the legislators are to be heard and to regulate the possibilities for fast delivery of shortages through parallel distribution and parallel import of deregistered products”, said Boryana Marinkova.