Farmak pharmaceutical company (Kyiv) is conducting pharmaceutical studies of medicines, which were manufactured by the company, in the United States and EU member states, chief scientific consultant at JSC Farmak (Ukraine) Viktor Marhitych said at a press conference at Interfax-Ukraine. “We are conducting a series of bioequivalence studies in the EU. We have very good generics. Their conformity is confirmed by bioequivalence studies in good clinics and laboratories. This is an important area of work that Farmak is doing,” he said.
According to the expert, soon a full research program will be soon completed for the Amizon preparation.
“This is so far our only original molecule, which we are developing according to the full program for original medicines. Over time, the drug research program should be fully implemented, the third phase of research should be completed, after which it will be possible to submit the drug for registration,” Marhitych said.
He said that huge investments are needed for the third phase of drug research.
“The third phase is hundreds of millions of dollars. We will consider how to attract such investments. Our founder, Filia Zhebrovska, said that the drug [Amizon], which is the best seller on the market, should be safe and effective. And we can confirm that the drug is safe and effective, and provide evidence, some of which are published, and another will be published,” the expert said.
In turn, the experts who conducted the research on the drug, in particular, Senior Researcher, Ph.D., at Research Institute of University of Illinois at Urbana Champaign (Chicago, U.S.) David Boltz; Professor in the Department of Microbiology and Director of the Global Health & Emerging Pathogens Institute at Mount Sinai School of Medicine in New York Adolfo Garcia-Sastre; group leader, Ph.D., University of Cambridge (Cambridge, UK) Aartyan te Veltuis and Regents Distinguished Professor & KBA Eminent Scholar, Ph.D., Diagnostic Medicine Pathobiology, Kansas State University, Manhattan, KS Jürgen A. Richt said that cooperation with Farmak started back in the 1990s. According to them, the drug itself is tested “for effectiveness on dozens of strains of viruses, it is proved that it is a powerful antiviral agent.”
Health Ministry of Ukraine has initiated rescheduling of a pilot project on 2D coding (the special QR code on packages) of medicine packages, acting Health Minister Ulana Suprun said at a press conference on Wednesday. “Due to the need to bring 2D coding into line with the EU requirements, we will initiate amendments into the government’s decree, which envisaged the launch of a pilot project from September 1, 2019. Producers and government agencies were not ready for this,” she said.
According to Suprun, profile associations backed rescheduling of the project, in particular because Economic Development and Trade Ministry failed to work out the procedures for introduction of this system.
Director General of Health Ministry’s Pharmaceutical Directorate Oleksandr Komarida has reported that the required amendments now are being drafted for the respective government’s decree and by the end of the week they will be put for a public discussion.
According to Chairman of the Board of Directors of the Association of Manufacturers of Innovative Medicines Vitaliy Hordiyenko, the amendments will affect the content of the information that will be encoded.
He noted that at present production sites of foreign manufacturers had necessary equipment for applying coding, however, it is not used for medicines manufactured for Ukraine, since manufacturers do not know what information the code should contain.
As reported, the Cabinet of Ministers of Ukraine approved a pilot project on introduction of 2D control marking and monitoring of medicines, which is part of the Concept for the Implementation of the State Policy for Prevention of Medication Falsification.
As expected, the project to be fulfilled from September 1, 2019 to December 31, 2020.
The number of clinical trials of medicines that are conducted in Ukraine could double by 2023, Ivan Vyshnyvetsky, the head of the Ukrainian Association of Clinical Research, has said. During the first congress of the association held in Kyiv, he noted that doubling the number of clinical trials conducted in Ukraine would be a strategic task for the association. “Undue pressure on researchers involved in clinical trials on the part of controlling and law enforcement agencies has recently increased. Obviously, to ensure a greater transparency of the process, it is necessary to improve the regulatory framework regulating clinical trials and eliminate the existing gaps,” the expert said.
He also stressed that the association intends to conduct a systematic educational work in order to dispel “myths and horror stories” about clinical research that circulate in the Ukrainian society. “Clinical trials that determine the efficacy and safety of drugs is a standard international practice aimed at increasing the availability of modern and innovative treatment and is used in all developed countries,” he said.
He told Interfax-Ukraine that currently about 200 clinical trials are being conducted in Ukraine. At the same time, over the past two years the reduction in the number of clinical studies has stopped.
The Ukrainian market needs three or five years to fully launch the QR code system for packages of medicines, Commercial Director of Research and Industrial Center Borschahivka chemical and pharmaceutical plant Yevhen Sova has said. “The implementation of the new rules is a step in right direction, but it is a long process, which should be prepared and introduced in phases. The Ukrainian market would require from three to five years to organically introduce the changes,” he told Interfax-Ukraine.
Sova said that the introduction of QR codes for packages would allow helping in fight against counterfeit medicines.
“We are preparing for this at Borschahivka chemical and pharmaceutical plant. The enterprise has installed specialized equipment for placing QR codes on packages,” he said.
The expert said that the monitoring system using QR codes would work only the general public approach at all levels of flow of medicines would apply.
Sova said that the introduction of QR codes on the Ukrainian pharmaceutical market could affect the cost of medicines.
Ukraine in January-February 2018 considerably increased exports of medicines to Russia, cutting their imports from the country. According to the State Statistics Service, in January-February 2018, Ukraine exported medicines for $3.5 million to Russia, which is 18% more than a year ago. Imports of medicines from Russia to Ukraine over the period fell by 40.4%, to $2.85 million.
Last year Ukraine exported medicines to Russia for $27.89 million, which is 31.9% more than a year ago, and imported medicines for $29.79 million from Russia (15.9% down). In 2017, Ukraine exported medicines for $171.17 million, including to the CIS for $143.057 million.
As reported, at present, because of the sanctions imposed on Russia, Russia is discussing the ways of replacing imported medicines and reducing dependence on foreign pharmaceutical companies. The decline in the imports of Russian medicines to Ukraine began after the introduction of the requirement of compliance of drugs with GMP standards in Ukraine.
Ukrainian pharmaceutical manufacturers have noted the need to resolve a number of issues related to the filling and application of the national list of essential medicines. Marketing and Sales Director of PJSC Farmak Susana Khalilova noted at present market participants do not have clear understanding of whether there will be the expansion of nosologies, according to which international nonproprietary names (INN) are included in the list, as well as the expansion of the number of molecules on the nosologies already included in the list.
“Currently we have the opportunity to apply for molecules, but we do not understand how we can justify the introduction [of drugs] for new nosologies, for example such as infertility, diabetes insipidus,” she said at a press conference at Interfax-Ukraine. Khalilova also emphasized the need to return the Fast Track procedure and simplify the introduction of changes regarding INN included in the list.
Commenting on the problem of applying the updated list at the local level, in particular the norm on 100% compulsory provision with drugs from it, she noted the difficulty of “how the coverage of this 100% need can be showed.”
Head of InterChem-Pharma Trading House Oleksandr Chumak, in turn, expressed the opinion about the need to approve such an edition of the list that would allow the Ukrainian market to plan its production.