You're reading: Ukraine’s medicines market may go into shadows again in 2013, say experts

Ukraine's medicines market may slip into the shadows next year if some imported drugs miss the March 1, 2013 deadline to undergo a new, mandatory import licensing procedure, says Executive Director of the Association of International Pharmaceutical Manufacturers in Ukraine Volodymyr Ihnatov.

“We could face a problem which disappeared several years ago – the shadow market of pharmaceuticals. If a medicine is not sold in the country, but it has been prescribed, there is a demand for it, and it will be offered by neighboring markets, and a large number of faked products will appear. According to the State Service on Medicinal Products, the counterfeited drugs rate in Ukraine is now between 2% and 2.5%, but this figure could considerably grow,” he said at a press conference at Interfax-Ukraine on Tuesday.

Ihnatov said a decline in medicines sales would most likely prompt an increase in their prices.

“Another option is bankruptcy – small-sized drugs stores and those in districts with a fewer outlets will go bankrupt,” he said.

Oleh Dobranchuk, the head of the Morion company’s analytical department, in turn said that in the first half of this year 694 international generic drugs that are available on the Ukrainian market are not produced in the country.

“If counted in packs, they account for 5.5%, and their share is about 15.1% of the market in monetary terms. This is the risk zone – these are the medicines that may not get onto our market when the licensing is introduced. Patients who take them may be left without medicated assistance,” he said.

Dobranchuk said that there are risks not only for foreign producers, but also for Ukrainian ones, as on January 1, 2013, the country is to introduce the EU’s Good Manufacturing Practice (GMP) requirements, and Ukrainian producers are dependant on imported raw materials.

“The GMP validation procedure has turned out to be very sophisticated, time-consuming, and not all the producers will manage to go through it by January 1. The procedure takes at least one year, taking into account the number of inspectors, and visiting inspections they could carry out,” he said.

Borys Danevych, the managing partner of Danevych law firm and member of the coordinating council for regulatory issues of the pharmaceutical sector under the Ukrainian Healthcare Ministry, said in turn that the GMP validation procedure does not always foresee checks on the compliance of a pharmaceutical plant, confirming only a document that has been issued to the plant by another country.