The Bulgarian medicines verification system, part of the unified European system, is ready for its official start on February 9, 2019 announced at the press conference Mrs. Iliana Paunova, executive director of Bulgarian medicines verification organization (BgMVO) and Mr. Deyan Denev, executive director of the Association of research based pharmaceutical manufacturers (ARPharM) and chairman of the BgMVO board.
“We are supported by the society, state institutions and largely by all stakeholders in the pharmaceutical supply chain. Patients protection and a greater transparency of medicines supply – these are the benefits of the verification process which are worth the efforts”, said Mrs. Paunova. Maybe there are technological issues for some participants in the process, making them resistant to the change and this is a natural reaction, she added. “Business interests may also be affected, as the verification process aims patient protection from falsified medicines in two directions: from the fake medicines themselves, but also preventing the legal supply chain from illegal entries of medicines. The latter carries a risk for the patients too”, stated Mrs. Paunova.
Mr. Ian Haynes, leading EU expert in the field of medicines verification, arrived particularly to attend the press conference. He presented to the journalists recent data about the problem of fake medicines dissemination and illegal supply in Europe and globally. During 2016 there were 347 incidents with counterfeit products in Europe, and above 3000 in the US, he said. This type of illegal business brings huge financial proceeds – about 500 times profit, showed Mr. Haynes’ presentation. The date 9th of February is not the end of our project, it marks the beginning of the practical implementation phase, underlined Mr. Haynes. The verification process protects firstly the patients, but also – the legal manufacturers, wholesalers and pharmacists, Mr. Haynes concluded.
“This is a stress test for the medicines supply chain, as 99% of all incorrect practices will be eliminated when the verification system is fully implemented”, commented prof. Ilko Getov, Chairman of Bulgarian pharmaceutical union, member of BgMVO board. He also reminded the guarantee given by the Health minister, Mr. Kiril Ananiev – there will be a smooth start of the system and no sanctions for the pharmacies will apply.
“We speak about a smooth process; the clock doesn’t stop on February 9th. A synchronization period will follow. To fulfill Directive’s 62 requirements was a challenge for Bulgarian manufacturers and it is an achievement for them to be ready on time despite the amount of investment and production volume. We shall celebrate an even bigger success at the end of current year”, said Mr. Nikolay Hadzhidonchev, Chairman of Bulgarian generics pharma association and member of BgMVO board.