“We feel like extras”. The All-Ukrainian Chamber of Pharmacy complained that lawmakers make decisions without discussing them with the professional community
Kyiv • UNN
The Head of the All-Ukrainian Chamber of Pharmacy criticizes the adoption of legislative decisions without discussion with the professional community. Experts warn about the risks of simplified registration of medicines and their potential danger to the public.
Legislative decisions related to the regulation of the pharmaceutical market are made without prior discussion with the professional community and often lack economic justification. Oleg Klimov, Chairman of the Board of the All-Ukrainian Chamber of Pharmacy, member of the Board of the International Federation of Pharmacists, member of the American Pharmacists Association, told this in an interview with UNN .
According to Oleg Klimov, Ukraine declares seven-mile steps to adapt all Ukrainian legislation to European standards, regulations and directives, including in the pharmaceutical industry. However, according to the rules of the European Union , professional non-governmental organizations are among those who are actively involved in the preparation of various regulatory acts.
"We are concerned that lately we have been feeling like a crowd in these processes, not participants, and we are not only not heard, but decisions are being made that have no economic justification, some slogans and nothing more," said Oleg Klimov.
He added that the All-Ukrainian Chamber of Pharmacy is actively analyzing the regulatory documents in force in the European Union.
"For example, we are looking into the initiative to allow these medicines to enter Ukraine without the registration procedure. Please forgive me, but as a pharmacist with many years of experience, I do not understand how this could be initiated, because Ukraine is a member of the international Pharmaceutical Inspection Cooperation System (PIC/S). Member countries have a simplified registration procedure. And here is a proposal to launch it, whoever wants and how they want. I'm sorry - this is, let's say, a time bomb that can simply destroy a part of the population of Ukraine, because no one will be responsible for quality control, the cold chain, and so on," said Oleg Klimov.
He noted that if such an initiative works, the drugs will be cheaper, because no one has gone through the registration and clinical trials, and these documents have not been approved by the regulatory authorities of Ukraine. "In our opinion, this is an unacceptable proposal, and I think it was prepared by people who are far from the healthcare system," he said.
At the end of November, the Verkhovna Rada supported in the first reading the draft law No. 11493, which was aimed at simplifying the registration of medicines for centralized procurement. However, the document may be amended before the second reading, which has caused a wide resonance and outrage among the pharmaceutical community. The main risks that experts point out are increased bureaucracy, complicated supply of medicines and a negative impact on the availability of medicines for citizens.
