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Ukraine will create European-style pharmaceutical regulatory state body - Health Ministry

A European-style pharmaceutical regulatory body will be created in Ukraine.

Deputy Health Minister Maryna Slobodnichenko said this in an interview with the Ukrainian News Agency.

"We need to create a powerful regulatory system. The pharmaceutical industry is more about the economy than about health care. Therefore, it is a matter of creating a powerful regulatory body that patients, manufacturers and other actors of the pharma market and our external partners would trust. This will strengthen the country's economy, ensure higher availability of quality medicines for patients and will raise the image of Ukraine in the international arena, and our manufacturers will increase exports," the deputy minister explained.

She noted that European countries buy Ukrainian pharmaceutical products, but these are not the volumes that the Ukrainian manufacturer and the Ukrainian market can provide.

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"Our country is a pharmaceutical generic market. That is, we produce analogues. Earlier, Europeans received these drugs from India and China, they had their own logistics routes... But today, starting with covid, it has become risky and a problem has emerged. And in this space someone must appear in order to become a reliable supplier of critical drugs in the EU, including antibiotics and other analogues. There is a Ukrainian pharmaceutical market, more than 130 pharmaceutical factories in Ukraine. But there must be trust in the Ukrainian system, in the regulatory process, a European integration reform of the pharmaceutical industry precisely from the point of view of creating a new powerful regulator," the official said.

Slobodnichenko added that there is a law that provides for the creation of a single regulatory body.

According to her, it will be an independent and almost self-supporting body, which assumes its impartiality and transparency.

There are no analogues of such a state body in Ukraine.

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"It will have a special status. It will not be a public body with minimum wages, which civil servants often complain about. The regulator will have the ability to determine decent wage levels for its employees. The special status will allow this body to provide a service and receive funds at transparent rates for business. Farm business needs fair, transparent and clear rules, which the new system will provide. Businesses are ready to pay fees, this is a clear system in EU countries. The body will ensure control of the market, the quality of medicines, medical products, cosmetics, as well as the registration of medical preparations," Slobodnichenko stressed.

The working name of the body is the State Control Body (SCB).

As Ukrainian News Agency earlier reported, Yuliya Tymoshenko, the leader of the Batkivshchyna party, said that two middlemen had artificially created a monopoly on medicine trade in Ukraine. Because of this, some medicines are several times more expensive than their counterparts in EU countries.

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