Those in the habit of pill-popping had better stock up. Ukraine’s pharmaceutical market is undergoing several changes that could affect supply and the price of medications, especially imported ones.
Up until the beginning of 2012, the registration of drugs in Ukraine was valid for a period of up to five years. According to the new regulations, however, registration is now indefinite, but more difficult to obtain. Apart from the Health Ministry and State Expert Center, companies also have to deal with a newly-founded special commission that oversees the registration of medications.
“Previously it took up to six months to register a new drug. Now it is hard to say how much time it will take as the process became much more time consuming and bureaucratic,” said Evgenia Paliy, an advocate at the Kyiv office of Gide Loyrette Nouel, which closely follows local pharmaceutical legislation.
Longer and more complicated procedures may lead to shortages of some pills in drug stores.
Moreover, importers have to make sure they get a Good Manufacturing Practice certificate – an international quality control attestation – for each producer by Jan. 1, 2013. After this date it will be impossible to register medicines in Ukraine, thus to import and sell them on the Ukrainian market without this document.
“This is a positive initiative in general, as there are many low quality products on the Ukrainian market,” Paliy said. “Considering the high quality standards, many medicines – around 2,000 items – won’t be let in the market as of next year. But the procedure of obtaining a GMP certificate is time consuming and authorities are not be able to issue enough certificates in time.”
Last but not least, the new legislation introduces obligatory licensing for imported medicines beginning March 1, 2013. And despite the fact that this deadline is approaching fast, there is no procedure or conditions for issuing such licenses yet.
Oleksiy Solovyov, head of the State Service on Medical Substances, said that tougher regulations on licensing drugs are required because of Ukraine’s committments with various European partners.
“European Union had a clear mechanism of regulation of import of medications… Import is licensed in the same way as production of drugs,” he recently told Apteka weekly.
He also said that Ukraine had a loophole in regulating the procedure for calling off drugs, and the new regulations address this problem.
But market participants are understandably worried about the new regulations.
Andriy Stogniy, general manager in Ukraine, Belarus, Moldova and the Caucasus at global healthcare conglomerate GlaxoSmithKline, pointed to the triple control of medications that are imported to Ukraine: registration, getting a GMP certificate and obtaining the import license.
“Such duplication of controls creates a threat of not being able to supply Ukraine’s patients with the medicines they need,” Stogniy said. “For instance, if an importer does not have a license, their medicines cannot be brought into Ukraine.”
A potential shortage of pills is not the only problem. Additional expenses in the form of licensing fees will be transferred from importers to consumers, which mean a price hike for imported remedies in Ukraine.
Experts say that obligatory licensing of imported medicines, a goal that Ukrainian authorities have frequently reiterated, is part of a state program for import substitution that was drafted to support the local production of pharmaceuticals in 2011-2021.
Ukraine’s drug market is expected to reach $3.3 billion in 2012, according to Proxima Research, an industry research outfit. That’s 15.6 percent more than in 2011. The share of local producers amounts to 68 percent in terms of the quantity of medicines sold. But the low cost of locally produced drugs means that when counted according to the value of goods sold, this falls to just 26 percent of the market.
On one hand, strengthening local alternatives is seen as a good solution to make consumers less dependent on profit-squeezing multinational corporations, while also potentially reducing prices. But Volodymyr Ihnatov, executive director at the Association of International Pharmaceutical Manufacturers said the policy of protectionism of local producers will negatively affect the industry in general and consumers in particular.
“If you shut the market down, you will never get either new technologies or know-how,” Ihnatov said. “You will end up back in the Soviet Union.”
Ihnatov added that lack of competition on the market will lead to a lack of choice for consumers and an increase in price of certain medications.
Kyiv Post staff writer Oksana Faryna can be reached at [email protected].
