Mandatory International Drug Manufacturing Standards Will be Implemented in Ukraine

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Mandatory International Drug Manufacturing Standards Will be Implemented in Ukraine

Starting from 2015, there will be mandatory International Drug Manufacturing Standards approved by the World Health Organization introduced in Ukraine to protect patients from poor quality drug use. This agreement was reached by patients and the Ministry of Health during the round-table discussion on May 31, 2012.

According to the document signed by the Ministry of Health, pharmaceutical companies and patients, WHO prequalification will be introduced in Ukraine for drugs purchased for state budget funds for patients with TB and HIV. Years 2013-2014 will be considered a transitional period, when manufacturing companies will have time to undergo certification.

«WHO prequalification procedure is free of charge for the manufacturers. It was developed by the international experts, and its main goal is to protect patients. Today, these standards have already been introduced globally, even in African countries» — says Bogdana Scherbak-Verlan, representative of WHO Country Office in Ukraine.

Today, in Ukraine all drugs purchased for money of the Global Fund to Fight AIDS, Tuberculosis and Malaria, in other words for money provided to Ukraine by other countries to control epidemics, are routinely prequalified by WHO and meet all international quality standards. But this assistance constitutes only 15% of all the drugs that come to Ukrainian hospitals and TB clinics today. 85% of them is purchased by the state, and the state currently does not require international standards of quality to be observed by the manufacturers.

«Today poor quality drugs purchased through the state budget to save money lead to severe complications and adverse effects in patients», states Dmytro Sherembey, Chairman of Ukrainian Community Advisory Board. «The drugs that we are talking today about are very specific and toxic. They require strict dosages and have to be of high quality. Even the smallest errors in dosages of some substances might lead to permanent changes in a patient’s body. Moreover, these drugs have to be taken on a day-to-day basis, and that definitely affects patient’s health. That is why international standards of manufacturing these drugs are of paramount importance.»

«Ministry of Health supports the application of up-to-date requirements to drug manufacturing confirmed by the inspection certificate PIC/S and WHO prequalification toward the process of drugs purchase for state budget money. This requirement will be enacted starting 2015, so we give time to pharmaceutical manufacturers to undergo all the required procedures or to receive confirmation from PIC/S and WHO», says Dmitro Pidturkin, Advisor to the Minister of Health.

«Yulia, my niece, have been taking such drugs for 2 years already, said a guardian of a 13-year old HIV-positive girl. — Every day the kid experiences severe side effects due to the drugs: starting from nausea to severe vomiting. Earlier, when she was taking other drugs, she didn’t experience that. She lost a lot of weight, looks drawn and haggard. We stopped taking drugs for some time, that, off course, tremendously affects Yulia’s health. We are hopeful that mandatory observance of international standards for pharmaceutical manufacturing in Ukraine will help increase their quality and resolve the problem that we face. Meanwhile, we are going to look for other drugs for our child and wait.»

Today over 600 thousand of Ukrainians live with diagnoses of TB and HIV. Mandatory WHO prequalification for drugs these people take on a daily basis is aimed in the first place at expanding their access to essential drugs that meet the necessary WHO recommended quality norms and standards.

Currently, out of 333 drugs in Ukraine available for treatment of TB and HIV 77 are prequalified by the World Health Organization.

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