The Third Partnering “Russian Medicines. An interdisciplinary dialogue” took place in Kazan on September 25. The main agenda of the meeting was drug provision and Federal Law 44 on contract system in public procurement. The event was organized by the Federal Antimonopoly Service, Ministry of Health of Tatrstan and the Association of the Russian Pharmaceutical Manufacturers. Over 300 of representatives of industry’s agencies and pharmaceutical companies took part in the meeting.
The event was moderated by Head of Department of Control on Social and Trade of the Federal Antimonopoly Service, Timophey Nizegorodcev and ARPM General Director, Victor Dmitriev.
“Novaris” and “Geropharm” will be the general partners of the Partnering. Also “NTFF Polysan”, “R-Pharm”, “Amgen”, “Ebbott”, “Petrovax Pharm”, “PharmEco”, “Nanopharma Developmentn” and “Takeda” are partners of the event.
The informational partners are “Pharmacevtichesky Vestnik”, “Vademecum”, “Mosccow Pharmacies”, “Remedium”, “GMP News” and “Pharmacy Union”.
For the first time in the history of holding the pharmaceutical Partnering, at the final session participants decided not to give prepared speeches, but to have an open dialogue with the representatives of the federal agencies and executive officers. For six hours they were answering most of the topical questions.
The participants discussed the issues of Federal Law 44. Timothey Nizegorodcev spoke about the mechanism of price settings on the essential drugs. Mr. Nizegorodcev noted that the main issue of the industry is the lack of competition. That leads to the need of state regulation of prices. Among the proposals, FAS suggests to stop using the “costal” approach and move to price registration based on the percentage of the price on the original medicine. It is also important to revisit the registry of the maximum sales prices and to set a maximum addition to the price of a medicine, which is differentiating based on the drug category.
The issue of the ZNVLP list (list of essential drugs) was also mentioned by Head of the Department of State programs and Price of “Novartis Pharma”, Krill Levashov. Mr. Levashov proposed a new approach of price formation of the maximum margins of the wholesale price. The margin has to count for logistics.
Representatives of the FAS spoke about law cases with regards to Federal Law 44. One of the issues is the creation of monopolies, which not only decreases the competition, but also to unreasonable price increase and decrease of drugs quality. The FAS have identified a cartel to maintain the prices at auctions in 2011-2012. The cartel united the leading pharmaceutical distributors, which were charged with administrative crime and had to pay 402 million Rubles.
Deputy Health Minister of Kazan, Farida Yarkaeva mention some unresolved issues of Federal Law 44. Those are the identification of the country producer; the status of the local producer and others. Mrs. Yarkaeva also said that if a drug produced at several plants the country of origin myst be defined via application. She also proposed to evaluate the idea to mandatory include drugs into the list of essential medicines, or to stimulate a company to apply for the essential medicine status.
Commercial Director of “Polysan”, Dmitriy Borisov noted the importance to check the purchased drugs (based on Federal Law 44) and those medicines that participate in the state auctions with their compliance with the GMP standards. According to Mr. Boris, only 62 out of 167 of the inspected manufacturers were GMP complained in 2014-2015.
The participants also disced the situation with the circulation of opioid drugs. According to Deputy Director of Health Care Department of the Primorye Territory, Ekaterina Eliseeva the main violations are in the are of transportation, storage and registration of narcotics. The issues of medical facilities are absence of licensing on narcotics, lack of qualified pharmacists, lack of state funds to create necessary conditions for storage and release of those medicines in the regions. The FAS on the other hand, finds only minor violations in medical facilities.
Head of the Federal Control Service in healthcare, Mikhail Murashko who submitted his welcoming speech to the participants noticed their productive work. “Today the professional cooperation between state authorities, business and medical community is very much in demand. We have common goals that involved precise and competent approach. Those issues are: the development of the domestic pharmaceutical industry, implementation of the state program of import substitution, design and introduction of the system of tracking if pharmaceutical products. In order to resolve those issues it is important to find a rational balance between interests of patients and economic interests of the domestic pharmaceutical companies. The Roszdravadzor as the controlling agency is very interested in the dialogue with the professional community and non-profit organizations. I am confident that jointly we will effectively and timely accomplish all the goals.”
“I am pleased with the openness, business attitude and professionalism of the participants of the Partnering. That is was attracts interested parties to come come to the traditional meeting place at the Study Center of the FAS. We are inviting everyone to come to the Fourth Partnering, in Kazan in September of 2016,” concluded ARPM Director General, Victor Dmitirev.