Patients suspended unreliable drugs trial on 60 Ukrainian people

Patients suspended unreliable drugs trial on 60 Ukrainian people

For more than a year already international and patient organizations tried to get precise information from Mili Healthcare pharmaceutical company about their new biosimilar product Peginterferon for HCV treatment. This drug was registered in 2010 and is now on its way for wide marketing in Ukraine.

At the same time, no reliable data on quality, safety and effectiveness of this drug was submitted to any governmental bodies. «It’s just ridiculous, when a company tries to say that data about the drug is confidential and belongs to the laboratory, where this trial was made. Even patients cannot receive this data — those people who will undergo this experiment». — says Olha Havrylova, UCAB deputy Head, CEO of the NGO «Stop Hepatitis».

Starting from November this year the company was going to start trial of the drug with unknown compounds and quality on Ukrainians, and for a couple of months was trying to aggressively recruit patients to it. «This piece of news was completely unexpected for us. There’s almost no HCV treatment in Ukraine while its price gains USD US$20,000 per year. And there are up to 3 mln. people living with HCV in Ukraine. Naturally, people will take any risk in order to cure this disease. Fortunately, patients intervened into situation, and the company declared that the trial will not be launched before our patient organization doesn’t have reliable data about the drug and approve trial protocol, which is going to be held in Ukraine.» said Dmytro Sherembey, the Head of UCAB, and the Director of Communication, Policy & Advocacy Department of the All-Ukrainian Network of PLWH.

Due to the presence of key governmental bodies at the meeting — the State expert Center and the Central Ethical Committee of the MoH of Ukraine — the patients managed to persuade the pharmaceutical company to register their trial in the state bodies according to the legislation of Ukraine.

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Additional information:
HCV epidemic represents one of the crucial health care problems in Ukraine and in the world due to its high prevalence and high chances of life-threatening states evolvement (inflammations, swelling of the liver).

At the same time, possibilities of Ukrainian patients to get high quality treatment are seriously limited. The reason for this is unreasonably low governmental commitment in solving treatment issues, extremely high prices for drugs produced by originator companies on the one hand and low quality of bio-similar drugs imported to Ukraine on the other hand.

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