Simplified Medicines Authorization System Launched in Ukraine

Simplified Medicines Authorization System Launched in Ukraine

Simplified Medicines Authorization System has been launched in Ukraine. The Ministry of Justice registered and published a corresponding Order of the Ministry of Health, ensuring that medicines authorized in USA, Switzerland, Japan, Australia, Canada and the EU may enter the Ukrainian market in 17 days! 

This step will allow significantly increasing the range of medicines in Ukraine, which is currently much smaller than in the majority of the European countries. For example, Ukraine has only 10 thousand authorized items of medicines, while in France this index is almost 16 thousand.

“Authorization of medicines has always been much regulated in Ukraine, which led to corruption,Oleksandra Ustinova, member of the Board of the Anti-Corruption Action Center reports. – This procedure usually lasts for 1-2 years and if a producer wishes the expedite the process, he was involved in the corruption micromanagement schemes, which allowed registering a medicine faster. Since now with the up and running simplified procedure for authorization of medicines authorized in the developed countries, it will be rather difficult to hinder the authorization process thereby expanding the range of medicines and facilitating pharmaceutical market competition.”

Thanks to the force of law the number of authorized medicines will increase in Ukraine. In the neighboring Georgia in the first year after the adoption of a similar law more than 500 medicines from the developed countries were authorized.

“Advanced treatment is almost inaccessible for the Ukrainians. Producers are not willing to authorize medicines in Ukraine because of complexities and corruption. Consequently, the patients in order to survive have to buy the medicines on the black market or smuggle them. For almost a year we have been struggling for adoption of progressive law and for simplifying the authorization procedure for the medicines from the developed countries. It is nonsense when the state creates barriers for authorization of the medicines authorized in the EU, USA, Switzerland, Japan, Australia or Canada. We call on the producers from these countries to get their medicines authorized in Ukraine as now this procedure takes only 17 days!”, says Olga Stefanyshyna, the Executive Director of the CF “Patients of Ukraine”.

It should be noted that the price for the medicines in Ukraine is much higher than in the neighboring countries. For example, Norvasc, a common medication for cardiovascular diseases, costs in Ukraine 20 (!) times more than in Hungary and 30 times more than in Latvia on the average. Price for another medicine, Plavix, is 12 times higher in Ukraine than in Latvia.

It is worth remembering that the initiative to simplify the medicines authorization procedure belongs to Volodymyr Groysman, the Prime Minister of Ukraine. A corresponding bill was registered in the Parliament as early as on April 20. However, in a few days the activists from the patient organizations found out that the ‘deregulating’ version of the document was replaced for the draft law specifying even stronger regulation of the pharmaceutical market. After the action “Let’s ruin the pharmaceutical barrier” the Prime Minister commissioned to hold a series of meetings with the experts and the public representatives, which resulted in the new text of the bill without corruption fall traps. The President Petro Poroshenko signed the Law of Ukraine No 1350 on June 16. In November the State Regulatory Services agreed upon the last bylaw regulating its operation and today the Order of the Ministry of Health has passed all stages for entry into force in accordance with the procedure.

Contact person: Aliona Romanyuk 093 72 10 800, aliona.r@patients.org.ua

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