Ukraine seeks greater control over pharma sector

Ukraine is proposing to boost the powers of the State Inspectorate for Quality Control of Medicinal Products and tighten the reporting responsibilities of pharmaceutical manufacturers as part of a concerted effort to combat the counterfeit drugs trade.

Measures included in the Cabinet of Minsters' proposal include a legal requirement to keep quarterly records of the identity and amount of medicines produced - including finished drug products and bulk ingredients - the amount sold during each quarter, and the remaining stock at the end of the reporting period, according to local news reports.

Under the current Prime Minister, Yulia Tymoshenko, Ukraine has experienced something of a revival in the State Inspectorate. However, a political deadlock ahead of the Presidential polls due in January 2010 means that it remains questionable whether the proposals will be acted on anytime soon.

This week, Ukraine President Victor Yuschenko (pictured) said he would veto a law, voted in by the country's Supreme Council last month, which would have brought in state control of the prices of medicines as well as other domestic goods.

Representatives of the pharmaceutical industry had argued that a moratorium on price rises could lead to pharmacy closures, reduced imports leading to shortages, and a proliferation of counterfeit medicines, according to Business Monitor International.

Some key pieces of legislation have been passed of late, including legislation governing Good Manufacturing Practice (GMP) requirements for drugmakers obtaining or renewing licenses, but "the broader policy-formation process has all but come to a complete stop," says the market intelligence firm.

Overall, the pharmaceutical and healthcare sectors in Ukraine "are in a state approaching chaos," according to BMI.

The lack of oversight of the pharmaceutical supply chain means that reliable figures for counterfeit medicines are not available, although reports citing prevalence of 20 to 40 per cent, and as high as 80 per cent for certain drug classes, have been published.