An investigation of Serbian-based Hemofarm opens questions on medication controls.
By Linda Karadaku for Southeast European Times in Pristina -- 21/08/12
The regulation of prescription drugs is increasing in state agencies for non-EU member countries. [Reuters]
State-controlled agencies in the region's non-EU countries are trying to control prescription medications entering their markets, but there is no guaranteeing the quality of the drugs bought on the black market or on the internet.
According to the World Health Organization, more than 50 percent of the drugs sold by illegal online pharmacies are forged and potentially dangerous due to a lack of quality control.
The Kosovo Ministry of Health buys nearly all the medicine for its public health institutions from the EU and the US.
"It has de facto excluded from the market medicines that come from less developed countries," Faik Hoti, director of communications for the Kosovo Ministry of Health told SETimes. Hoti said that the country has also blocked the import of medicines manufactured in Serbia.
In late June, the US Food and Drug Administration (FDA) sent a letter of warning to Serbian-based drug company Hemofarm about its findings in its inspection of this company in November 2011. The agency prohibited the use of Hemofarm medications for "significant violations" of manufacturing practices.
Hemofarm was purchased from Germany's Stada Arzneimittel AG for 480 million euros in 2006.
The Hemofarm violations included the methods used in, facilities or controls used for, manufacture, processing, packing and holding medications. The FDA specified that all articles manufactured at Hemofarm remain under FDA import alert until its manufacturing practices are in compliance.
The agency said these failures led to an occurrence of the deadly Burkholderia cepacia bacterium, which can lead to rapid lung failure.
"Our Agency for Drugs and Medical Devices controls products from Hemofarm, and it has no knowledge that their products present any danger to human health," former Serbian Minister of Health Zoran Stankovic told SETimes.
The Serbian Agency for Drugs and Medical Devices did, however, ask Hemofarm to send them the information on the case.
The Kosovo Ministry of Health buys the majority its of medication from the EU and the US. [Reuters]
Patrick Meschenmoster, spokesman for Stada Arzneimittel, said the warning is in connection to its plant in Vrsac, which was going through a production redesign when it was inspected by the FDA. The warning letter refers to problems that the company had already addressed during the inspection, he said.
The FDA warning has no impact on the company’s profitability, Meschenmoster said, because it had stopped production because of poor market conditions in the US.
Kosovo has decided to continue blocking imports of Hemofarm products until the situation is clarified. Regardless, Hoti said, Serbian medicine products present a very low percentage of the Kosovo market.
In neighbouring Macedonia, the Bureau for Pharmaceuticals ordered urgent control of the products imported from Hemofarm. There were no bacteria found in the products sold in the Macedonian market, so the import of all Hemofarm drugs resumed.
EU countries have their own mechanisms to control the medication quality circulating in the Union. The European Medicines Agency is a decentralised agency in the EU responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in member countries.
"Across the European Union, the competent authorities for medicines regulation in the member states ensure that medicines are consistently produced and controlled to the quality standards appropriate to their intended use," Monika Benstetter, a press officer for the European Medicines Agency, told SETimes.
The top categories of articles detained on EU external borders in 2011 were medicines (24 percent), packaging materials (21 percent), cigarettes (18 percent), clothing (4 percent), accessories for mobile phones (3 percent) and labels, tags and stickers (2 percent).
In terms of number of articles detained in postal traffic, medicines remained the category's top at 36 percent. Products that would be potentially dangerous to the health and safety of consumers -- suspected trademark infringements concerning food and beverages, body care articles, medicines, electrical household goods and toys -- accounted for a total of 28.6 percent, almost double the amount as in 2010 due to the increase in medicines.
Serbia-based Hemofarm is under investigation for "significant violations." [Hemofarm]
Benstetter says good distribution practice ensures that the level of quality determined by the CGMPs is maintained throughout the distribution network, so that "authorised medicines are distributed to retail pharmacists and others selling medicines general public without any alteration of their properties."
It also ensures "compliance with the principles and guidelines is mandatory within the European Economic Area and is controlled by the national competent authorities for medicines regulation."
In June 2011, the EU adopted a new directive on the prevention of falsified medicinal products entering into the legal supply chain, by introducing EU-wide rules for the import of active substances.
The new directive introduces harmonised safety and strengthened controls across Europe by applying new measures, including obligatory features on medicine packaging, strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients, an obligation for manufacturers and distributors to report any suspicion of falsified medicines and an logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.
Member states will have to start applying these measures in January 2013.
"Every company that produces drugs sold on the Macedonian market has a legal obligation to notify us immediately if there is some breach of the quality standards. In this case we had no such warning. Nevertheless, we ordered the control [on Hemofarm products," Ilco Zahariev, director of the Macedonian Bureau for Pharmaceuticals Bureau, told SETimes.
Every year in Macedonia, approximately 600 drugs from different producers are tested, collecting samples from pharmacies by chance selection. Their microbiological quality is tested in the laboratories of the Institute of Public Health and the Faculty of Medicine in Skopje.
"Kosovo allows the import of those medicines which are registered in Kosovo, which possess an authorization and certificates testifying their quality and good production practice. There is a good control of the medicines that come to the market. The medicines are imported through the registered and licensed pharmaceutical companies," Hoti told SETimes.
SETimes correspondents Biljana Lajmanovska in Skopje and Biljana Pekusic in Belgrade contributed to this report.