Health ministry intends to annul simplified registration of medicines - Patients of Ukraine

Health ministry intends to annul simplified registration of medicines - Patients of UkraineUkraine's Health Ministry intends to revoke the simplified registration of medicines applied in countries with tough regulation initiated several weeks ago by Ukraine's Cabinet of Ministers, Executive Director of Patients of Ukraine Olha Stefanyshyna said at a briefing this week.

She said that these provisions submitted by the Health Ministry are outlined in the amendments to government bill No. 4484 on the deregulation of the pharmaceutical market in Ukraine submitted to the Verkhovna Rada on May 10, 2016.

"When the prime minister at a cabinet meeting said that he seeks to deregulate the pharmaceutical market, it was a miracle for us. Patients of Ukraine were glad to see the bill appeared on the parliament's website two weeks ago and it was a progressive measure. However, several days ago we revealed that the document was replaced: the bill registered by the prime minister was completely changed. We know that the Health Ministry submitted proposals to the bill, and that it now has no influence over access to vitally important medicines," Stefanyshyna said.

A partner of Arzinger law firm Lana Sinichkina said that the Health Ministry introduced two provisions in the bill that complicate the medicine registration procedure in Ukraine.

The Health Ministry proposes to restrict a list of medicines with fast track down to those, which have no branded equivalents in Ukraine. This means keeping current pharmaceutical market monopoly in place and restricting competition. The ministry also added several 'blurred' requirements obliging applicants to submit information and documents according to a list, which is not specified.

Read also: Ukraine's PM wants to simplify access of medicines to Ukrainian market

The lawyer said restriction of competition on the pharmaceutical market would result in increased prices for pharmaceuticals.

"The worst thing is that the proposed changes came from the Health Ministry. This means that today's ministry is actually lobbying for the interest of some pharmaceutical manufacturers, instead of protecting patients and sincerely attempting to expand accessibility to medicines," Sinichkina said.

Stefanyshyna said Patients of Ukraine asks the government to return to the initial version of the document.
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