Stock of some unique medicine created in Ukraine due to threat of stopping imports from Jan 1
Kyiv, December 26 (Interfax-Ukraine) – Some foreign producers of vitally important medicine which do not have analogues in Ukraine have created one-year or two-year stocks of its products in Ukraine due to a threat of stopping their imports from January 1, 2013, the head of the State Service for Medicine, Oleksiy Solovyov, said at a press conference at Interfax-Ukraine on Tuesday.
He said that the producers failed to pass a procedure for verifying their correspondence to Good Manufacturing Practice (GMP) and from January 1, 2013 companies which do not have a quality certificate for medicine will not be able to supply their products to the Ukrainian market.
"At present, 21 items of unique medical products are in the group of risk… The State Service for Medicine in early December held talks with the producers [from France, Italy, India] so that they create a one-year stock of medicine. They guaranteed that during 2013 they will submit documents for confirmation of GMP," Solovyov said.
Among medicine, which supplies are under a threat of failure, will be Sigedrine (Hydrazine sulfate) used for treating cancer (a stock of 32,000 packages has been created), Neupro (Rotigotine) for treating parkinsonism (a one-year stock has been created) and Dacogen for treating cancer (a two-year stock has been created).
Solovyov said that Ukrainians from January 1, 2013 will not see around 1,300 imported medical products that were produced in the insanitary conditions, which had been confirmed by checks.
"We won’t have such medicines next year… Today there are no risks for patients," Solovyov said, adding that all of the 1,300 products are fully duplicated by the national pharmaceutical industry and by companies from Eastern Europe.
Co-Chair of the Healthcare Committee at American Chamber of Commerce in Ukraine, Borys Danevych, said that not all of the companies are able to quickly supply the required number of medicine before January 1, 2013.
Medical Director at Movement for Health Union of NGOs Dmytro Koval added that existing Ukrainian analogues are often less effective.
Executive Director of the European Business Association (EBA) Healthcare Committee Natalia Serhiyenko said that the main problem for European producers which have been operating under the GMP standards for a long period of time was the inconvenience and imperfectness of the procedure for verifying GMP in Ukraine, and they failed to finish it.
"The procedure has a lot of drawbacks. Many companies even did not have a chance to pass it, as it is too inconvenient and foresees the submission of a large number of documents and their check. It's not enough time before January 1 from the point of view of companies' possibilities and from the point of view of the possibilities and resources of the State Service for Medicine," Serhiyenko said.
The EBA and American Chamber of Commerce asking to postpone the date of the introduction of a requirement to verify GMP by importers of medicine by four months – until May 1, 2013.
As reported, medicine importers were obliged to provide a certificate of quality for medicines, which is in line with GMP requirements, under cabinet resolution No. 793 dated August 8, 2012.